prospectus - igmpiindia · 2020-02-13 · prospectus certificate programmes in (3 months advanced...

PROSPECTUS

CERTIFICATE PROGRAMMES IN

(3 Months Advanced Programme)

GMP for Finished Pharmaceuticals & GoodManufacturing Practice in Manufacturing,Processing, Packing, or Holding of Drugs.

GMP In Manufacturing, Packing, or HoldingHuman Food

Food and Drug Regulatory Agencies Process Analytical Technology Documentation in QA & QC Department Registration of Drug and Dossier Preparation (CTD

and eCTD submissions) Drug Registration (European market) Drug Registration (GCC countries) Drug Registration (African countries) Drug Registration (India) WHO-GMP

Drug Registration (US Market-ANDA, NDA etc) Preparation and Submission of Drug Master File (DMF) Prescription to OTC Switch Computer System Validation Pharmaceutical Validation Computer Aided Drug Design (CADD) Good Clinical Practices (GCP) Analytical Testing and Equipment Sterile Manufacturing Naturopathic Science Quality by Design Chemical Safety HVAC Systems Validation Certificate in Quality Management System for Medical

Devices (ISO 13485)

IGMPIInstitute of Good Manufacturing Practices IndiaGlobal accredited training & certification providerConferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD &ASSOCHAM Services Excellence Award 2017

Trusted by organizations & training participants in over 30 countriesTraining | Certification | Education | Research

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IGMPI

About IGMPIInstitute of Good Manufacturing Practices India, registered as a non-profit society ( under The Societies Registration Act,1860) with Government of India recognised by the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, accredited Vocational Institution of Ministry of HRD, Government of India, approved training Institute of Food Safety and Standards Authority of India (FSSAI) and affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council of National Skill Development Corporation (NSDC) -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.

Our group of learned professionals from above mentioned sectors of the Pharma, Healthcare and Food industries have put together their knowledge; know about and practical experiences in form of this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as stronger and better training platform provider for professionals and students in the aeas of GMP, Quality Assurance and Control, Pharma, Food and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of quality healthcare and foods is known to our founders and thus numerous efforts are being made to offer friendly but effective and easy regular, part-time and online/distance sources of GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice in form of formal classroom studies, distance/online/interactive courses, online seminars, as well as onsite training programmes along with knowledge of worldwide affairs of the industry; in short a round-the-clock help for any information in these areas needed by anybody from around the world. Based on high standard of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC etc areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India.

The IGMPI's team of technology experts and other Industry advisors together pursue to make cGMP knowledge, training in the area of Pharma and Food manufacturing easily accessible, through this platform.

IGMPI

Accreditation and AwardsInstitute of Good Manufacturing Practices India (IGMPI) is registered as a non-profit society with its own Memorandum of Association and bye-laws under The Societies Registration Act, 1860, Government of India.

IGMPI is recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India and is an accredited Vocational Institution of Ministry of HRD, Government of India (AVI no-710367) and all the courses of IGMPI are approved for life time empanelment under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh also.

The quality based Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of following criteria:

1. Course Content

2. Course Design

3. Course Material

4. Instructors

5. Class size & Attendance

6. Facilities

7. Evaluation of Students

8. Written Examination

9. Certificate

IGMPI is also an ISO 9001:2015 Certified Organisation accredited under Dubai Accreditation Center (DAC), Accreditation Department, Government of Dubai, UAE and has been conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD – Certificate of Merit 2015 & ASSOCHAM Services Excellence Award 2017.

IGMPI is affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC) as well.

IGMPI is an approved Training Institute of Food Safety and Standards Authority of India (FSSAI)(FSSAI ID: TPINS18) IGMPI PHARMA® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.

IGMPI is a PMKVY (Pradhan Mantri Kaushal Vikas Yojna) affiliated training partner ( SMART TP Number: Tp010908)

IGMPI also offers International Register of Certificated Auditors (IRCA) Accredited Lead Auditor course periodically.

IGMPI is also registered under Section 23 (2), Rule 56 (1), Trade Marks Act, 1999, Government of India (Reference No. 2738626).

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Quality Council of India (QCI)Quality Council of India is set up by the Government of India to establish and operate national accreditation structure and promote quality through National Quality Campaign. QCI is registered as a non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38 members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.

National Skill Development Corporation (NSDC)The National Skill Development Corporation (NSDC), working under the aegis of the Ministry of Skill Development and Entrepreneurship, is an apex organization for skill development in the country. The NSDC is responsible for overseeing the many Sector Skill Councils as well as other skill development and promotional activities across the country. It also implements many Government of India skill schemes such as Pradhan Mantri Kaushal Vikas Yojana (PMKVY) and UDAAN.

NSDC was set up by the Government of India as part of the national skill development mission in order to fulfill the growing need for skilled manpower across sectors. The Chairman of NSDC is nominated by Government of India.

ADVISORY BOARD AND TEAMDr. Mahesh C Gupta, Chief Advisor: Dr. Mahesh C Gupta is an experienced and internationally reputed Scientist in the field of calibration, quality assurance and testing. He has worked with many government organizations like National Physical Laboratory (NPLI), New Delhi for 32 years and later with Dubai Central Laboratory, Dubai as Principal Quality Officer. He has also played a vital role in developing lab accreditation program of India as Head National Calibration Program. He is also the founder president of Indian quality association. He has expertise and proficiency in various fields like calibration, GLP, analytical techniques, quality assurance, laboratory inter-comparison, proficiency testing, QMS and many more. With his knowledge and rich experience, he is focused on practical aspects of current needs, contemporary and emerging trends, besides alerting the laboratories for future challenges. A PhD from Indian Institute of Technology (IIT), New Delhi, Dr. Mahesh C Gupta has been associated as a research fellow of Optical Society of India, Fellow of Indian Society of Lighting Engineers and Vacuum society of India. He is also currently managing Lab World Magazine –a renowned world class magazine dedicated to Quality Testing and Calibration laboratories in all sectors- as the Editor in Chief.

Mr. Vinod Kumar Arora, Principal Advisor: Mr. Vinod Kumar Arora is an internationally acclaimedindustry professional having 35 years of rich experience in pharmaceutical development in the areas of Generics, Differentiated, NDDS/NCE Dosage Forms. He is now associated with IGMPI as an advisor.

He joined Ranbaxy in 1983 where he initially worked as scientist for almost 4 years. He rejoined Ranbaxy in 1994 where graduated to Vice President level from Assistant Director position. During his association with Ranbaxy he developed products - Generics, Differentiated Generics, NDA's and NCE-Global, market specific and OTC. Prior to his association with Ranbaxy, he worked as an Assistant General Manager with the Formulation Development Research in Cadila Laboratories, Ahmedabad and helped in setting up of Onco-manufacturing facility and developed several oncology products. He has expertise in Dosage Form development in the area of dosage forms – Solids -Tablets / Capsules / Granules / Pellets /PFOS/TFOS; Non-solids –Liquid /Injectables including Lyophilised/Topicals, Inhalations – DPI/ pMDI and Nasal Spray, Dosage Forms Technology such as Nanotechnology, Depot Injection; Modified Release tablets/suspension, Self-Emulsifying System, Oro dispersing tablets/oro -

dissolving strips; Particles/Pellets coating and has good understanding of current Good Manufacturing Practices and QA/QC. He has made presentations to NDAC Committee for New Drugs Approval in India, had meetings with Oman MOH and Pre IND meetings with USFDA. He has also authored/coauthored over 100 patents in the area of NCE/ Differentiated products /NDDS/Generics. With his knowledge and rich experience, he is focused on practical aspects of current needs, contemporary and emerging trends, besides alerting the pharmaceutical industries for future challenges. He is holding many honorary positions -Member of Indian Pharmacopoeia Scientific Body , Panel member of INMAS-DRDO, Ranbaxy Science Foundation Scholars Award , Global Expert committee member of DFE Pharma , Germany and Distinguished Scientist from World Whos Who

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Society , Member of Indian Pharma Committee of Make in India Campaign etc. He was felicitated by Hon'ble former President of India, Dr A P J Abdul Kalam for development and launch of first NCE – Anti malarial from India. Mr. Vinod Arora is a M. Pharm degree holder from BHU and DBM from IMM, New Delhi. As one of our principal advisors he will be supporting our initiatives nationally and internationally to rest of faculty members of IGMPI in imparting education, training and continuing education programs as well as our knowledge dissemination initiatives like Current GMP,QA/QC, Regulatory affairs ,Clinical research guidelines and news updates.

Mr. Syed Q. Abbas, Advisor: An eminent and a dynamic person, with a rich experience of 37 years in the food Industry. Prior to associating with IGMPI, Mr Abbas has been working in the Food Corporation of India under both state and central governments in the various departments. He has specialized experience in Storage and Preservation of food grains, Quality Assurance and Quality Control & Supply Chain Management. He has a rich exposure in food safety and quality. He has successfully carried out audits, faced CAG and statutory audits for food safety and quality in the FCI. He has provided trainings and has organized a series of workshops for food professionals. He is presently active in providing our Faculty of Food Safety & Quality his valuable leadership to take it to the new level in the future.

Ms. Rajni Jha, Advisor: Ms. Rajni Jha, an expert professional in International Regulatory Affairs and Quality Assurance for APIs for US, European as well as Asia-Pacific markets completed her M.Sc. and Post M.Sc Research work from I.I.T., Kanpur. She has more than 20 years of rich experience working with various pharmaceutical companies like Ranbaxy, Morepen Laboratories, Torrent Pharma, Nicholas Piramal, Unimark Labs, Glenmark Generics and Indswift Labs Ltd.

She is associated with IGMPI for development of training modules , e-lectures, personal lectures, workshops etc. Owing to her skills and proficiency; she had been leading a team of both RA and QA personnel from different departments. Her key responsibilities and roles included submission of API Dossiers including Drug Master Files (DMFs), Technical Data Packages (TDPs) and their updates, Supplements, Amendments, Responses to Queries of different Intermediates & APIs for Filing purposes to Regulatory authorities of various countries as per current global Regulatory guidelines for approvals across all markets (USA, Europe, Australia, Latin America, Asia Pacific, Russia, etc.), development and upgradation of various Protocols /Checklists for CQA as well as RA, assessment of various outsourced DMFs and maintenance of existing DMFs, preparation and streamlining of SOPs, etc. She has also successfully completed USFDA, PMDA, TGA, MHRA and Greece Authority audits for GMP compliance for outsourced intermediates and APIs as a part of QA function. She has attended various conferences/seminars on Regulatory Affairs, Quality Assurance and compliance through both domestic and International training programs. She has also been actively involved in imparting internal training and creating awareness on current GMP requirements, data generation with respect to regulatory requirements and updating of systems with current regulatory requirements across different departments in various organizations through training modules and workshops.

Dr. Manjusha Rajarshi, Advisor: Dr. Manjusha Rajarshi has more than 20 years of rich experience in the pharmaceutical industry (various companies -Bayer, Aventis Pasteur, Unichem, B. Braun); Her various career moves from training department, medical department, clinical operations and regulatory affairs and medical affairs. Her industry exposures include: Clinical trial sites and sponsor sites audited for GCP compliance; PV skills assessed via PV inspections of EMA from global headquarters; for 4 years, Local Person Responsible for PV, with Servier, India. She is honourable member of i) the Medical Committee with OPPI (organization of Pharmaceutical Producers of India), member of the committee for deliberations of GCP guidelines, PV guidelines to the Indian

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Regulatory Authorities ii) Pharmacy Council of India (PCI), iii) Indian Society of Clinical Research (ISCR), iv) Indian Association for Statistics in Clinical Trial. Besides, therapeutic areas handled by her arecardiology, diabetology, venous diseases, neuro-psychiatry, vaccines and many other internalmedicinal therapies. She has more than 25 publications published on behalf of international journalssuch as IJCP, American Journal of Cardiovascular Drugs, Neurology, International Journal of Cardiology,Diabetes Research etc

Ms. Amrita Bhattacharya, Associate Professor: Amrita is associated with IGMPI as an Associate Professor. She is engaged in developing modules, e-lectures at her best in the disciplines of Good Manufacturing Practices, Clinical Research, Quality Assurance, Quality Control, Pharmacovigilance, Public Health & Hospital Administration. She has worked with many pharmaceutical & healthcare companies like many pharmaceutical companies like Fortis Clinical Research and Jubilant Clinsys having more than 6 years of experience. She has successfully conducted clinical studies for US FDA, EMEA, DCGI & for several reputed Pharma companies. She is also having technical expertise in conducting Clinical Trials Phase I & Phase II. Amrita has also performed pre-qualification and post-qualification audits for Quality Assurance & Quality Control & Good Manufacturing Practices. Amrita has completed her graduation in Microbiology from Lady Amritbai Daga &Smt. Ratnidevi Purohit College for Women, Nagpur and Master's Degree in Biotechnology from Rani Durgavati University, Jabalpur.

Ms. Sneha Gupta, Senior Faculty Member: She is a highly experienced Regulatory Affairs professional with exceptionally positive personality. She has specialized experience in managing all kinds of Regulatory and Start-up activities for Clinical Research (across multiple therapeutic areas), Product Registrations, Quality Management, Training Workshops and Conferences for India and South-east Asia. She possess working knowledge of key International Regulations (that of USFDA, EMEA, Health Canada and WHO) for the Pharmaceutical and Clinical Research Industry. Ms. Sneha is a “Certified Trainer” for clinical trials regulatory affairs and corporate behavior. Her academic profile encompasses B. Tech in Biotechnology and Masters in Clinical Research along with a Certificate Course in IntellectualProperty Rights (IPR). Also, she has undergone professional trainings/certifications in Schedule-Y andIndian GCP; Good Laboratory Practices (GLP); IPR and TRIPS Agreement; Preparation, Filing andReview of Regulatory documents; Guidelines for Cosmetic Registration and Import and many others.Apart from Regulatory and Study Start-Up Operations Management, her areas of expertise includeQuality Control and Internal Quality Audits of Regulatory Documents; Strategic Risk Management andMitigation Strategies; Client Management & Retention Negotiations; Business development; Trainingand Development; and Strong Analytical and Content Development Skills. She has attained wealthyproficient experience as a Regulatory affairs professional by serving for 8 years in differentorganizations like Jubilant Clinsys Pvt. Ltd., Asiatic Clinical Research, Lambda Therapeutic Research;Indian Council of Medical Research; and GVK Bio among others which has eventually helped herdevelop excellent working relationships at Regulatory Agencies and Scientific Committees. Snehaauthored an article titled “Implications of Drugs Going Off Patent” published in magazine “LifescienceIndia” and has co-authored a chapter on “Anti-Retroviral Medication” for a book on ClinicalPharmacology by Dr. S. D. Seth. She also writes a blog named CheersZindagi.

Ms. Priyanka Kapoor, Senior Faculty Member: A passionate professional working as a Quality assurance and training expert in the field of Clinical Research for the last 7.5 years. Her professional skills include designing and implementing Quality systems within organizations; Performing audits for all Clinical Study phases and BA/BE studies; Preparation and review of SOP's, Protocols; Managing

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regulatory and sponsor inspection and performing Vendor Qualification Audits. She has gained rich industry exposure from Fortis Clinical Research Ltd, Ranbaxy Research Laboratories and others. Ms. Priyanka has done research work on 'Method development and validation for analysis of molecules on LC-MS/MS extraction procedure' and 'Biological sample analysis for submission of ANDA'. She has also worked as a part of Regulatory Inspection Management Team and faced inspection from FDA, ANVISA, MHRA, WHO etc. Her academic credentials include B. Pharm and M. Pharm (Pharmaceutical Chemistry) with a Post Graduate Diploma in Clinical Research and Pharmacovigilance and Clinical Data Management. She has two research papers published to her name on “Effect of extract of Zizyphus mauritiana Linn, Root on bacteria causing diarrhoea” in Insian Pharmacist Nov, 2004 and “Pharmacognostical features of Zizyphus mauritiana Linn” in Ancient science of life, Sept 2004.

Dr. Sunita Sharma, Associate Professor: A life science professional, Dr. Sunita Sharma has more than twelve years of research exposure on Industrial pharmaceuticals. Being proficient in diverse areas of strain improvement, process development and fermentation based pharmaceuticals; she has deep interest & vast exposure in GLP/GMP & patent infringement. She also has adequate knowledge of International regulatory guidelines. She has also been associated with Ranbaxy Laboratories Limited as a group leader in the department of fermentation and International Drug Regulatory Affairs. There she has been entrusted with submitting Drug Master Files/Registration Dossiers for in-house manufactured APIs to various regulatory authorities. As per her academic experience, she has worked as a lecturer over three years in the department of microbiology, School of life Sciences, Guru Nanak Dev University, Amritsar. Apart from these, she is also an Ex- Member of Board of studies and Board of control of Microbiology department, Guru Nanak Dev University, Amritsar, India. She has completed her B.Sc, M.Sc and Ph.D. from School of Life Sciences, Guru Nanak Dev University, Amritsar, India.

Dr. Shikha Kumar, Advisor: Dr Shikha Kumar is one of our faculty members and trainers. She has deep interest and vast exposure in GMP training, writing pharma & healthcare related modules and regulatory documents. She has completed her bachelor's in pharmacy from K.N.M.I.P.E.R, Modinagar and her master's in pharmacy from I.T B.H.U, Varanasi. She has also completed her Ph.D from Hamdard University, New Delhi. Apart from these, she is also trained in regulatory affairs and in medical and clinical research writing. She has worked for a couple of pharmaceutical companies i.e. Eli Lilly and Torrent Pharmaceuticals Limited. There she has been entrusted for manuscript writing for non-clinical and clinical studies, compilation of CMC and IMPD for IND filling in UK and India. She has about 15 research articles as an author and about 10 publications as a medical writer in peer-reviewed journals. She has also done patent writing and medical letters writing. During her job in pharma companies, she has also written protocols, investigator's brochure, scientific reports and newsletters for clinical trials. She is fond of writing health related articles and regulatory documents.

Ms. Pooja K. Arora, Advisor: Pooja K Arora, a Healthcare industry professional has acquired her Master's degree in Clinical Research from Cranfield University, UK and professional Diplomas in Pharmaceutical Industry Regulatory Affairs and Pharmaceutical Management from reputed institutes. She has been associated with Clinical Research associate with a few CROs and thus had hands on working basis of the industry. She is presently associated with IGMPI as one of its advisors.

Dr. Snehal Singh, Advisor: Dr. Snehal Singh has a diverse experience of more than 8 years in medical/ scientific/ E-learning and educational writing, which includes good manufacturing practices, clinical research and scientific documents, medico-marketing material, training manuals, E-learning coursem modules, patient education material and educational counseling. She has worked with esteemed organizations like Institute of Preventive Cardiology, Oxygen Healthcare Communications, Satyam

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BPO and Novartis Healthcare Pvt Ltd. She is a qualified medical professional (B.H.M.S) and has earned Post Graduation in Hospital & Healthcare Management (PGDHHM) and in Preventive & Promotive Health Care (PGDPPHC) on her name. She has also worked as an editor to several health magazines like Health and Wellness, Alternative Medicine, Nutrition and fitness, Pregnancy, Parenting and Child health. She is also experienced in imparting corporate training and training material development.

Ms. Shikha Thakur, Assistant Professor: Shikha Thakur is working with IGMPI as an Assistant Professor. She is responsible for developing training modules e-lectures, personal lectures delivering her best of knowledge and skills in the domain of Quality Control, Quality Assurance & Good Laboratory Practice.

She is currently also indulged in providing assistance to our senior faculty members in the finalization of training modules' syllabi, content and methodology and conducting e and personal lectures. She is an alumnus of ISF College of Pharmacy, Punjab Technical University, Jalandhar, where she did her Bachelor's and Master's programme in pharmacy with specialization in Quality Assurance. As her remarkable achievement, she is a recipient of DST sponsored PTU fellowship for project entitled “Solubility enhancement of Arteether: Formulation Development and Optimization. She has been entrusted with responsibility of helping advisors and Director General of the Institute in providing the distance cum e-learning and regular participants and trainees with experiential training in the areas of Quality Assurance and Quality Control, Regulatory Affairs, Clinical Research and Good Laboratory Practice.

Ms. Harshita Sharma, Assistant Professor: Currently as an Assistant Professor, Harshita is working on training modules development and co-ordination with an objective of achieving larger mission and goals of the organization. With deep interest and academic excellence in the areas of Pharmaceutics, Quality Assurance & Quality Control, Regulatory Affairs Good Manufacturing Practices and Intellectual Property Rights, she keeps a close watch on latest developments in the Industry. In addition to these responsibilities, she is playing a key role in setting up Project Training division of IGMPI. Harshita has completed B. Pharmacy from Maharaja Surajmal Institute of Pharmacy, IP University, Delhi, and M.Pharmacy with specialization in Pharmaceutics from ISF College of Pharmacy, Punjab TechnicalUniversity, Jalandhar and is a Ph.D. scholar in the Faculty of Pharmacy, Jamia Hamdard University, NewDelhi. Aside from her regular association with IGMPI, she is presently designated as an independentNon-Executive Director in Medicamen Biotech Limited as well.

Ms. Dilrose Pabla, Assistant Professor: Dilrose Pabla has taken up the responsibilities of assisting senior faculty members and advisors of the Institute in development of training modules, e-lectures, training kits, regulatory guidelines etc. Quality Assurance & Quality Control, Regulatory Affairs, Intellectual Property Rights, Nanotechnology & Good Manufacturing Practices are her areas of interest and exploration. She is also playing a key role in organising guest lectures by eminent Industry professionals. Dilrose has completed B. Pharmacy from Sigma Institute of Pharmacy, Gujarat University, Ahmedabad, and M.Pharmacy with specialization in Pharmaceutics from ISF College of Pharmacy, Punjab Technical University, Jalandharand is a Ph.D. scholar in Punjab Technical University.

Ms. Ankita Gururani, Assistant Professor: An industry professional with management experience, Ankita Gururani has been associated with implementation of quality assurance in FMCG sector. She has completed her Bachelors in Medical Microbiology from H.N.B Central University and Masters in Microbiology from Amity University, Noida. Apart from these, she has also acquired acertification on Patent Analyst and has thorough knowledge on IPR, database searches. SWOT, CI, patent portfolio and landscaping. She has also worked with Britannia India Ltd., where she was been entrusted with the

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responsibility of conducting internal audit programs and implemented QNN and 5S as part of manufacturing excellence. At IGMPI, Ankita has an important role to play in the development of the course content and training modules in the field of food safety and quality assurance with an objective of achieving larger mission and goals of the organization.

Ms. Neharika Thakur, Assistant Professor: A logical thinker with immense aptitude for research and development work, Ms. Neharika is a work-driven spirited member of the IGMPI team. She has completed her B.Sc. in Food Technology from Delhi University and M.Sc. in Food Science and Technology from Pondicherry University. Ms. Neharika has qualified UGC NET in Home Science and ICAR NET in Food technology multiple times. Being an active member of the research community, she has authored a few research publications in international journals and her work with “Utilization of deoiled peanut cake in bakery products” is particularly noteworthy. With her sporty spirit and resolution to leave no work incomplete, she is a constant source of inspiration for the students as well as faculty members. Prior to joining IGMPI she has worked as Assistant Professor in ITM University, Gwalior and had research exposure at ICAR institute. At IGMPI, she is involved in lecture delivery and research guidance while conducting interactive sessions with the students.

Ms. Sangita Borah, Assistant Professor: Ms. Sangita is a competent professional with experience in biochemical studies, food quality testing, equipment handling, and research & development. As a part of Faculty of Food Safety and Quality, she is responsible for developing training module, lectures and research in the domain of food processing and technology. She has qualified ICAR-NET in Food technology and her academic credentials include Masters in Food Processing and Technology from Tezpur University, Assam and graduation in Biotechnology from Shillong. She has always been a keen participant of international conferences, seminars, and workshops in the field of food safety and quality improvement of food supply chain. Prior to joining IGMPI, she has worked as Research Analyst in Rai University and Sr. Research Fellow (SRF) in Tezpur University.

Ms. Akanksha Bhandari, Assistant Professor: As a young trainer, known for her vibrant presence and unmatched dedication towards work, She has taken the responsibility of imparting a whole new meaning to IGMPI’s resolution of knowledge dissemination. Ms. Bhandari is a B. Pharm, M. Pharm qualified professional from Punjabi University with a Certification in Intellectual Property Rights. She has an impressive hold over the concepts of pharmacovigilance, clinical research, regulatory affairs, good manufacturing practices and is proficient in handling of sophisticated equipments. Her areas of interest include Patent searching, drafting, & writing specifications, Novel drug delivery systems, and Modified release oral dosage forms (Formulation Optimization). Her industrial exposure encompasses IDS Infotech and BRD Medilabs for production and analysis of oral liquids and tablets. Prior to IGMPI, She has worked at Galgotias University, Department of Pharmacy as Assistant Professor.

Mr. Joshua Martin, Assistant Professor (Food Technology): Joshua has an important role in the development of the course content and training modules. His field of interest is food safety, FSMS, GMP, HAACP & other standards and food packaging. He has a rich exposure to a variety of Food Industries as a consultant in terms of Food Safety. He is an M.Tech in Food Technology with specialization in Food Process Engineering from SHIATS-DU, Allahabad. Prior to joining IGMPI he was also associated with Nestle. He is a FSSC 22000 certified lead auditor from SGS, India.

Ms. Bhawna Sharma, Assistant Professor: Bhawna is working with IGMPI in the development of training modules, lectures and assisting the senior faculty members in teaching, training and research. She is having technical competence and interest in the field of Clinical Research, Good Manufacturing Practices and Pharma Product Management. She has completed M. Pharmacy with specialization in

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Pharmacology from P.D.M. College of Pharmacy, PGIMS University, Haryana and B. Pharmacy from Hindu College of Pharmacy, PGIMS University, Haryana.

Ms. Nisha Rani, Assistant Professor and Programme Co-ordinator: She is involved in the development of training modules, lectures and assisting the senior faculty members in teaching, training and research. She has technical competence and interest in the field of Regulatory Affairs, Intellectual Property Rights and Good Manufacturing Practices. She has completed her B.Pharmacy and M. Pharmacy with specialization in Drug Regulatory Affairs from Maharishi Dayanand University, Rohtak, Haryana and qualified GPAT, 2012.

Ms. Garima Mishra, Assistant Professor: With a good hold over pharma subjects, impressiveinteraction skills and a sincere learning attitude, Ms. Garima has teamed up with the IGMPI staff inpreparation of modules and lecture development. She has keen interest in Organic chemistry,Medicinal Chemistry & Pharmaceutical analysis and taken lectures on the subjects in reputed pharma colleges. Her industrial exposure encompasses Akums Pharmaceuticals Pvt. Ltd, Ind-Swift, UNICHEM, Alembic and others. She has completed B. Pharm and M. Pharm (Pharmaceutical Chemistry) during her academic tenure. She has various research papers published to her name in Asian Journal of Pharmaceutical and Clinical Research, International Journal of Pharmacy & Life Sciences and International Journal of Medicinal Chemistry and Analysis and many others on the way. She has published a book named “Method development and validation by Gas chromatography”, and co-authored “Dissolution Enhancement Using Different Formulation Approaches” and Lap Lambert academic publishing (USA).

Ms. Geetanjali Rai, Programme Coordinator: Ms. Geetanjali is a highly experienced professional with excellent administrative skills. At IGMPI, she is mainly responsible for setting up effective systems and processes for smooth execution of administration work. She is a multi-tasker with experience in providing Management, Marketing as well as Administrative support to all parts of the work. She is known for a consistent ability to accurately maintain computerized and manual filing/ documentation systems along with answering and resolving queries precisely, in a courteous and confident manner. She has earned proficient skills from her tenure at Max Hospital, Lupin Pharmaceuticals Ltd. and Streatham Place Surgery, London, UK.

Ms. Bhavna Khattar, Programme Co-ordinator: Bhavna's key role is to assist our Advisors in the coordination and execution of our programmes and training modules. She also has good interest in academic deliverables and research in the areas of Good Manufacturing Practices, Quality Assurance and Quality Control, and Regulatory Affairs, IPR etc. She has completed B. Pharmacy from Jaypee University, Solan. Prior to joining IGMPI, she was working with Bioplasma Immunologicals Research.

Ms. Satarupa Ghosh, Programme Coordinator: She has completed B.Sc in Biotechnology Hons. from Royal School of Management and Technology, Utkal University, Bhubaneswar, Odissa and M.Sc. in Biochemistry from Boston College for Professional Studies, Jiwaji University, Gwalior. She has done specialized training related to HLA B27 typing and possesses hands-on skills on other routine diagnostics in Molecular diagnostic division learnt from SRL Religare Laboratories, Gurgaon. She has also done PG. Diploma in Clinical Research from Hyderabad. Presently, her role in IGMPI encompasses development of training modules providing assistance to senior members of the staff.

Mr. Deepanshu Soni, Technology Officer: With a rich experience in Software Development, Web Development, application development, Deepanshu works as a Technology Officer and is responsible for all the technical works and new initiatives at IGMPI in order to make our Learning Management

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System (LMS) and other web services to our training participants and students user friendly. He also possesses technical competence and interest in the areas of code development, web design etc. He has completed his B. Tech in Information Technology (I.T) from Vindhya Institute of Technology and Science, R.G.P.V University, Bhopal.

Ms. Rafat Abedi, Director: Rafat Abedi is our Investor & Director. She has been investing in this nonprofit making organization with the primary objective of knowledge dissemination in Good Manufacturing Practices. She looks after administration of IGMPI, training co-ordination, training kits and study materials development and entire logistics for IGMPI. She has previous rich experience in education, training and co-ordination of computer application and management programs.

Mr. Syed S. Abbas, Director: Owing to his academic achievements and interests Syed Abbas has gained work knowledge of several sectors of the business industry, in his career span of twelve years. His contributions to the Pharma and healthcare industries development studies are numerous. Some of the generous ones count around the esteemed projects, work models, business agendas and organisational setup works he has plotted, guided and worked for in the education and Training Industry, Information Technology industry, Pharmaceutical Research Industry, non-governmental organizations, and many others. He has completed Masters in Public Administration from Lucknow University and Executive MBA from Indian Institute of Management (IIM), Lucknow. He is a member of Indian Pharmaceutical Association (IPA).

As an operations head of IGMPI, he with his experience has been guiding and advising sincerely to bring forth a whole new bouquet of easy learning and training tools for all those using or planning to use or otherwise interested in gaining knowledge about Good Manufacturing Practices.

ADVISORY FACULTY FROM INDUSTRYApart from regular faculty members, eminent and dynamic industrial professionals having rich industrial experience of upto 35-40 years have got associated with IGMPI in regular, part-time, distance cum e-learning and Continuing Education Programme (CEP).The industrial professionals who have joined IGMPI in this initiative have worked in reputed pharmaceutical companies like Ranbaxy Laboratories Ltd,Cadila Pharma Ltd, Dr.Reddy's Laboratories,Quintiles,IPCA, Cipla etc in the areas of GMP,GLP, Clinical Research, QA/QC, IPR, Regulatory Affairs, Drug Discovery, Public Health, Medical Coding etc.The continuing education training programme has been launched with an initiative to provide training to work force in the industry on specific topics in short time period and to quick fix the issues with possible solutions by having an interface with senior industrial professionals.

IGMPI

Certificate Programmes in

GMP for Finished Pharmaceuticals & For Manufacturing, Processing, Packing, or Holding of Drugs.

Personnel in pharmaceutical industry should be familiar with the basic GMP requirements and become familiar with technical terms from the field of GMP and their meaning. The course is directed to staff from the pharmaceutical industry having less exposure to current GMP requirements. This includes both employees who are fresher in pharmaceutical industry and experienced colleagues who work for the first time in a GMP-regulated environment.

The case study based approach in certificate programme via distance cum e learning mode is designed for working professionals in full time employment who want to update their knowledge and gain required skills in the area. This course is beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced course having rigorous case studies based methodology throughout the duration. The training in GMP imparted by IGMPI is approved and certified by Quality Council of India, Government of India.

IGMPI Certified ModulesModule 1 : Basic Principles of Good Manufacturing Practices

Module 2 : Good Manufacturing Practice for Finished Pharmaceuticals and for Manufacturing,Processing, Packing, or Holding of Drugs

Module 3 : Complaint Handling and Product Recall

Module 4 : Deviation Management, CAPA And Change Control

Module 5 : The Indian GMP Regulation

Module 6 : Computer System Validation

Module 7 : Importance and Principle of Data Integrity

Module 8 : Case Studies

Future career prospects of the programmeGMP and its applications are not restricted to manufacture of solely pharmaceutical drugs but extents to variety of other consumer products. GMP is the only and the best tool to ensure production of quality safe products. So knowledge of the same could help those aspiring to join industry or those targeting to set up one such manufacturing unit. After completion of this course, professionals can work as production manager, production executive, production officer, production team leader.

IGMPI

GMP in Manufacturing, Packing or Holding of Human Food

Good manufacturing practices (GMP) are essential to any organization looking to reduce the risk and liability that can result from poor handling within a food operation. This programme come across common dangers associated with manufacturing. This programme helps in management of organization's processes and ensuring complete control over general hygiene procedures and environmental contaminants. This course is beneficial for professionals from different streams who wants to start their stint in food sector or interested in updating their knowledge. Improved knowledge of GMP, Enhanced ability to identify potential food safety risks from GMP, Correct implementation of GMP and Compliance with global best practice are some of the benefits of programme.

The case study based approach in certificate programme via distance cum e learning mode is designed for working professionals in full time employment who want to update their knowledge and gain required skills in the area. This course is beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced course having rigorous case studies based methodology throughout the duration. The training in GMP imparted by IGMPI is approved and certified by Quality Council of India, Government of India.

IGMPI Certified ModulesModule 1 : Introduction to GMP and Food Industry

Module 2 : Indian Food GMP

Module 3 : GMP in manufacturing, packing or holding of human food

Module 4 : Validation and Verification for Food Industry

Module 5 : Conducting and facing first, second & third party audits

Module 6 : Complaint Handling and Product Recall (Food Industry)

Module 7 : CAPA and Deviation management (Food Industry)

Module 8 : Industry based case studies.

Future career prospects of the programmeFrom health care product manufacturing to biotech products, food and beverage manufacturing, GMP is the only best tool to ensure production of quality safe products. This certificate programme provides adequate knowledge for more specialized roles like quality manager, food safety officer, production executive, food safety standards consultant and many more. After completion of this course, professionals can work as production manager, production executive, production officer, production team leader.

IGMPI

Food and Drug Regulatory Agencies

This program is intended to provide with a basic understanding of the areas of regulatory affairs and quality operations to give a thorough and up-to-date knowledge of food and drug regulatory agencies as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical, medical device and food products. The programme aims to equip the participants with the educational foundation that will help them advance in the regulatory affairs profession. The course will provide the fundamentals required in regulatory affairs.

The case study based approach in certificate programme via distance cum e learning mode is designed for working professionals in full time employment who want to update their knowledge and gain required skills in the area. This course is beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced course having rigorous case studies based methodology throughout the duration.

IGMPI Certified ModulesModule 1: Regulatory agencies for Food (International perspective)

Module 2: Regulatory agencies for Drugs (International perspective)

Module 3: Regulatory agencies in India

Module 4: Regulatory Compliance requirements in India and other major markets

Module 5: Industry specific case studies

Future career prospects of the programmeThe regulatory affairs market has always been of a fluid nature due to the constant changes in regulations in the world and Regulatory adherence is imperative for obtaining and maintaining marketing authorization. The knowledge gained from this course regulatory affairs is essential for continued success of pharmaceutical and food industries within the world to get approval and authorization. The course will empower the students with the tools required to successfully navigate the minefield i.e. GCC, FDA, TGA, EU and other regulatory affairs compliance systems. The course will ensure that participants are completely up to date with the latest in legislation. These courses equip the participants with the knowledge and confidence to instigate the optimization of the in-house regulatory procedures. After completion of this course, professionals can work as regulatory associate, regulatory officer, documentation analyst, documentation specialist.

IGMPI

Process Analytical Technology

This course provides an overview of PAT applications in pharmaceutical operations. At the end of the course, participants will get to know the PAT life cycle, PAT applications likely to yield positive benefit, understand issues of organizing and managing a PAT project and integrating the principles of Quality by Design into the effort.

Process analytical technology (PAT) is becoming a very important tool for controlling pharmaceutical processes and when implementing Quality by Design. This course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT.


IGMPI Certified ModulesModule 1 : PAT Vision and Framework

Module 2 : PAT in Development, Manufacturing, Automation control system, Quality by design, Process validation etc.

Module 3 : Introduction to Quality by Design (QbD)

Module 4 : Technology Identification and assessment

Module 5 : Industry based Case Studies

Future career prospects of the programmeProcess Analytical Technology is becoming a very important tool for controlling pharmaceutical processes and while implementing quality by design. This course provides an overview to the tools and principles outlined in the FDA guidance. This course is very useful for professional engineers, scientists and managers involved in pharmaceutical drug substance or drug product manufacturing and development, quality assurance and regulatory affairs. After completion of this course, professionals can work as analytical development scientist, quality technician, and analytical PAT scientist.

IGMPI

Documentation in QA & QC Department

This course has been designed to impart knowledge and practical understanding about the quality assurance department and quality control department with special emphasis on documentation. This course utilizes tools to guide each participant through the steps of quality assurance working and managing quality documentation procedures in pharmaceutical companies.

The case study based approach in certificate programme via distance cum e learning mode is designed for working professionals in full time employment who want to update their knowledge and gain required skills in the area. This course is beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced course having rigorous case studies based methodology throughout the duration. The training in Quality Assurance and Quality Control imparted by IGMPI is approved and certified by Quality Council of India, Government of India.

IGMPI Certified ModulesModule 1 : Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare

industries

Module 2 : Role of QA & QC and Good Documentation Practices

Module 3 : Quality Documentation: Requirement and Industry Expectations

Module 4 : Industry based Case Studies

Future career prospects of the programmeQA and QC are quiet essential parts of pharmaceutical, biotech and all other verticals of the healthcare industry. The course utilizes tools to guide each participant through the steps of quality assurance working and managing quality documentation procedures in pharmaceutical companies. This course is beneficial for professionals from different streams to help them intensify their knowledge. After completion of this course, professionals can work as documentation analyst, documentation specialist, quality manager, quality analyst.

IGMPI

Registration of Drug and Dossier Preparation (CTD and e CTD submission)

This course takes through the essential steps for submitting electronic submission to the regulatory agencies and Research (CDER) and can serve as a resource for questions about the submission process. The eCTD format has become mandatory in key markets for electronic submissions. This course, while focusing on the US requirements, also provides a quick overview of current regulatory guidelines of eCTD in major world market including North America, the European Union etc. It aims to introduce tools to assist the participants in formulating effective strategies in the development, compilation, and submission of US-compliant eCTDs

This course is designed for professionals of the biotechnology and pharmaceutical industries who are currently, or planning to become, involved in the development of regulatory submissions using the electronic Common Technical Document (eCTD). The program is particularly suitable for project team members interested in gaining a practical understanding of regulations, tools, and required submission processes. This includes professionals working in Regulatory Affairs / Regulatory Operations, Submissions Management, Authors of CTD Sections, Technical and Clinical Writers, Documentation Teams, Project Management and Information Technology and Information Systems.


IGMPI Certified ModulesModule 1 : Market authorization & electronic submission in major markets

Module 2 : Registration of Drug and Dossier Preparation (CTD and e CTD submission)

Module 3 : Drug Registration, CTD and e CTD submission in India.

Module 4 : Industry specific case studies

Future career prospects of the programmeThis course provides a comprehensive description on the Common Technical Dossier structure - completely updated to reflect the latest changes in pharmaceutical regulatory affairs. After completion of this course, professional will be able to identify the recent requirements for developing drug substance and drug products and setting up a registration dossier. After completion of this course, professionals can work as regulatory associate, regulatory officer, documentation analyst, documentation specialist.

IGMPI

Drug Registration (European Market)

This programme provides a comprehensive description and discussion of the regulatory environment. The Comprehensive Training on European Regulatory Affairs including different Registration Procedures and Variations. This is a unique opportunity to learn, understand and discuss the main aspects of drug regulations in Europe directly from key European Regulators and from the large experience in the pharmaceutical industry and to acquire key recommendations for a successful implementation of regulatory strategy and operations.


IGMPI Certified ModulesModule 1 : Drug Registration in Europe

Module 2 : Comparison of Drug Approval Process in US and EuropeModule 3 : Dossier preparation in CTD Format, eCTD Submissions

Future career prospects of the programmeThe objective of these courses is to impart knowledge and practical understanding about the drug registration procedures that are available and the structure of the registration dossier. Professionals who are willing to have a successful career in regulatory affairs, registration and documentation for European Countries, GCC Countries, India, US market should attend this course. These courses are highly recommended for those who are aspiring to move into regulatory affairs from other areas within a pharmaceutical company. After completion of this course, professionals can work as regulatory associate, regulatory officer, documentation analyst, documentation specialist.

IGMPI

Drug Registration (GCC countries)

The Gulf Cooperation Council (GCC) region is considered as “Emerging market” for pharmaceutical export and bilateral trade. The course has been designed with the view to impart knowledge and understanding of Drug Registration Procedure in GCC countries, Regulations, Registration procedure, country specific Common Technical Documents, GCC guidelines and dossier preparation.


IGMPI Certified ModulesModule 1 : Introduction to Global Regulatory Authorities for Pharma industries

Module 2 : Overview of the GCC countries and Drug Registration

Module 3 : Registration of Innovative Pharmaceutical Products in GCC countries and submissionof dossier

Module 4 : Pharmaceutical Import & Export Procedures in Gulf Countries



IGMPI

Drug Registration (African countries)

The objective of this course is to impart knowledge and understanding of Drug Registration Procedure in African countries - Regulations, Registration procedure, Country specific Common Technical Document guidelines and dossier preparation. Course includes hands on training on country specific dossier preparation. This course utilizes interactive learning tools to guide through the steps of drug regulation and registration process for the African countries.


IGMPI Certified ModulesModule 1 : Introduction to Global Regulatory Authorities for Pharma and Pharma industries

Module 2 : Overview of the African countries and Drug Registration

Module 3 : Registration of Innovative Pharmaceutical, biotech Products, Generic and Biosimilar products in African countries



IGMPI

Drug Registration (India)

This course provides integrated knowledge and broad perspectives required to effectively manage the regulatory process for approval of new drugs in India. This course targets all Pharma manufacturer/importer, regulatory, preclinical, formulation scientists, and clinical trial professional who are involved directly or indirectly in new drug registration process. The course modules covers new drug including fixed-dose combination in India. Ever-changing laws and regulations require regulatory affairs professionals to cater the current needs of industries for the global competition so as to effectively bring their medicinal products to the Indian market with less time.


IGMPI Certified ModulesModule 1 : Regulatory Overview in India and Regulatory Dossier

Module 2 : Registration of Drug in India

Module 3 : Drug Registration, CTD and e CTD submission in India.



IGMPI

Drug Registration (US Market-ANDA, NDA etc)

This course targets the training needs of executives who are or will be involved in the preparation of development plans and/or registration dossiers. Tougher regulatory approval processes pose challenges for pharmaceutical companies registering drugs in the USA.

This certificate course develops understanding of all the current procedures in the challenging environment of US. By attending this 1 month programme, practical insight will be gained into FDA's requirements for new drug development and preparation of new drug registration dossier accordingly to US guidelines. This course will provide benefit in terms of:

Faster drug registration in the US.

Needs, expectations and regulatory requirements of the FDA for the drug registration dossier

Preparation of successful Investigational New Drug Applications (INDs) & New Drug Applications(NDAs)


IGMPI Certified ModulesModule 1 : Drug Registration in USA

Module 2 : IND, NDA and ANDA submission



IGMPI

Preparation and Submission of Drug Master File (DMF)

This course is designed for professionals to provide an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. This course will explain step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. This will be of great benefit to regulatory compliance professionals working on DMF, NDA, IND or ANDAs, Regulatory affairs professionals, attorneys, project managers, and management professionals in small and mid-size manufacture operations.


IGMPI Certified ModulesModule 1 : Drug development process and regulatory filings

Module 2 : Introduction to Drug Master Files and its Types

Module 3 : Preparation and Submission of Drug Master File


Future career prospects of the programmeThe DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. Attendees will learn the differences between the five types of DMFs and the detailed information required within each type of DMF. Using a series of case studies, the course will highlight real word examples and actual experiences with FDA submissions related to DMF components. Upon completion of the course, attendees will be able to begin developing or to improve upon their DMF file documentation. Professionals working in manufacturing, Regulatory affairs, research and development, QA and QC, validation and development and preparation of submission material will be highly benefited by this course. After completion of this course, professionals can work as regulatory associate, regulatory officer, documentation analyst, documentation specialist.

IGMPI

Prescription to OTC switch

Self-care is becoming increasingly popular among health care consumers. Due to the availability of over-the-counter medications it is possible to treat numerous ailments without the supervision of a health care professional. This course is designed to provide sufficient education regarding the safe and effective use of over the counter products.


IGMPI Certified ModulesModule 1 : Introduction to Prescription to OTC switch

Module 2 : Regulation on Prescription to OTC switch


Future career prospects of the programmeAccelerated OTC market growth will also come from greater consumer involvement in self-treatment. Healthcare is costing more out-of pocket to the consumer. This encouraged consumers to seek out information and more knowledgeably select and purchase the lower-priced OTC alternatives. By opting for this course, the candidate will have better knowledge of OTC medication and their safe use and supporting regulation and can work as regulatory associate in the team working in this area. After completion of this course, professionals can work as product manager, product management director.

IGMPI

Computer System Validation

Computer validation is more than a compliance requirement. It not only reduces regulatory risk, but it also increases understanding of system during project implementation and enforces a structured, well-defined execution of the project. Pharmaceutical Computer System Validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time. Subject matter expert (SME) of CSV will have a major role in achieving these benefits. This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts. This course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.

IGMPI Certified ModulesModule 1 : Qualification & Validation

Module 2 : Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation

Module 3 : Software Quality Audit -Implementation in Life science verticalsModule 4 : GAMP 5 and documentation

Module 5 : Importance and Principle of Data Integrity

Module 6 : Case Studies

Future career prospects of the programmeCompanies, particularly the life science industries must validate their information technologies (such as computer systems, software that run on them and infrastructure components) to ensure they meet the intended business needs. Computer System Validations involve activities primarily around generating requirements and specification documents, testing the systems against those specifications, documenting test results and writing final reports. There is definitely a bright career path if one is willing to learn about personnel process and technologies.

Computer System Validation field had enjoyed an explosive growth since the early 90’s. IT professionals, software vendors and developers, research, development and manufacturing associates and scientists, healthcare and clinical professionals, quality management professionals and technical project managers are dedicated to this field and the need is steadily growing as technology evolves and regulations increase. After completion of this course, professionals can work as computer system validation specialist, validation engineer, validation consultant/analyst, QA consultant, IT validation analyst.

IGMPI

Pharmaceutical Validation

This Certificate Programme has been designed to help manufacturers gain awareness of quality requirements regarding validation and the nature of “special processes”. This programme targets Quality, Product Development and Manufacturing personnel involved in process validation, Regulatory Affairs Managers and auditors of manufacturing firms (internal and external).

This certificate reduce development time with better understanding of validation, faster market access with more compliant products, Increase sales and customer satisfaction with professional development and knowledge sharing. The validation programme is ideal for anyone in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who is tasked with validation.

The case study based approach in certificate programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GMP professional in the domain. This certificate is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certificate having rigorous case studies based methodology throughout the duration.

IGMPI Certified ModulesModule 1 : Quality, Quality Assurance and Quality Control

in Pharmaceutical and Healthcare IndustryModule 2 : Introduction to Validation Module 3 : Validation: Ins and Outs

(FDA and WHO perspectives)Module 4 : Quality Control checks, Inspections and AuditsModule 5 : Government Regulations and Certifications,

ICH guidelines and ISO 9000Module 6 : Computer System Validation

Module 7 : HVAC Systems Validation

Future career prospects of the programmeThis course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help them to integrate and link the science and risk-based lifecycle approach for Validation to your Pharmaceutical Quality System. Validation professionals evaluate and calibrate the equipment and procedures used in development and production of a variety of products. They ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products. After completion of this course, professionals can work as validation specialist, validation engineer, validation analyst.

IGMPI

Computer Aided Drug Design (CADD)

Drug, discovery and development is an intense, lengthy and an interdisciplinary endeavor. The contribution of computational methodologies has revolutionized the process of drug discovery. It is a powerful tool in the study of relationship between molecular structure and biological activity and thus essential in the process of rational drug design. Now days, major world’s pharmaceutical and biotechnological companies use computational design tools. This Computer Aided Drug Design course covers all main computational techniques used in drug discovery, supplying a basic level of knowledge of this research field. This technique will provide a unique platform to all researchers working in this field to screen new drug entities.

IGMPI Certified ModulesModule 1 : Concepts and Principles in CADD – 2D and 3D QSAR

Module 2 : Molecular Modeling and Pharmacophore

Module 3 : Virtual Screening and Molecular Dynamics

Module 4 : Molecular Docking

Module 5 : Advanced Concepts in Bioinformatics: Homology

Module 6 : Proteome based Technology: Concepts, Principles and Application

Future career prospects of the programmeDrug design, through computer, is a most recent, exceptionally viable strategy in present day field. Computer Aided Drug Design (CADD) could be utilized for generation of effective drug agents (inhibitor) against disease (target). As a result of this, a large number of candidate drugs have been developed till now. This course is very helpful for those professionals who are interested in making their career in the field of drug, discovery and development and research industry. After completion of this course, professionals can work as research scientist, CAD designer, design technician.

IGMPI

Good Clinical Practices (GCP)

Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable. This certificate programme is aimed at improving the conceptual knowledge of the participant for Good Clinical Practices and resolving any dilemmas that a working professional may face regarding the application of GCP guidelines at his workplace. Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study material has been carefully designed to introduce the attendee to various aspects and basics of GCP, its need and benefits in assuring the ethical and scientific integrity of clinical trials.GCP compliance provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. Several specialized topics have been added to guide the participant through ICH GCP regulations, compliance needs, comparison of Indian GCP guidelines vs. ICH GCP guidelines etc.

IGMPI Certified ModulesModule 1 : Introduction to Clinical Trials

Module 2 : Overview of ICH- GCP Guidelines and its new revision

Module 3 : Principles of ICH GCP- Responsibilities, Sponsor, Investigator and Ethics Committee

Module 4 : Essential Documents- Informed Consent, Protocol and Investigator's Brochure

Module 5 : SAE Reporting, Audit & Inspection

Module 6 : Consequences of GCP non-compliance

Module 7 : GCP Guidelines for Medical Devices


Future career prospects of the programmePharmaceutical professionals need to ensure that their skills should be up-to-date with the latest regulations. The good clinical practice guidelines ensure that clinical trial participants are protected during the research process. This certificate course will help professionals, strengthening their skills and experience in this field.

IGMPI

Analytical Testing and Equipment

Analytical testing is a very important component of quality testing and validation of pharmaceutical products. In a pharmaceutical laboratory, a lot of work is being done on analytical equipments. Thus workforce trained in handling such equipments is always in demand. IGMPI offers an opportunity to act as a trained technician handling such equipments.

IGMPI Certified ModulesModule 1 : Introduction to Pharmaceutical Analysis

Module 2 : Analytical Testing and its Scope

Module 3 : Basics of Spectroscopy

Module 4 : Basics of Chromatography

Future career prospects Analytical testing is an essential part of pharmaceutical, biotech and all other verticals of the healthcare industry. The course is more profitable for the person who wants to make their career in various industries which works with pharmaceuticals, chemicals, cosmetics, and analytical testing laboratories, etc. This course has been tailored to suit the needs of employed as well as yet to be employed candidates targeting to take over the analytical division of the industry.Job roles and positions like that of laboratory assistants or technicians in reputed pharmaceutical companies.

IGMPI

Certificate in Sterile ManufacturingWithin the framework of pharmaceutical production, the most demanding requirements apply to sterile manufacturing and aseptic production because this is the most critical process for the manufacture of medicinal products. Sterile manufacturing is an important aspect of pharmaceutical industries as there are certain pharmaceutical products that cannot be produced/ sterilized by the normal processes. In order to better understand the process and its intricacies, students can pursue this course from IGMPI to gain access into the sterile product sector in pharmaceutical industry.

IGMPI Certified ModulesModule 1 : Sterile pharmaceutical products and their Formulation

Module 2 : Requirements for Sterile Product Manufacturing

Module 3 : Sterilization processModule 4 : Clean-room design, qualification and operationModule 5 : Quality Testing and Control

Future career prospects This course is intended for those having specific responsibilities or wants to make their career in the area of sterile manufacturing. It will be of particular value to those in research, development, production, quality assurance and control. Job roles and positions like that of shop floor level production assistants or technicians in reputed pharmaceutical companies, cosmetic manufacturing units, wherever production of such specialized products like parenterals and opthalmic preparations is being carried out.

IGMPI

Module 6 : Vaccine manufacturing processesModule 7 : Regulatory standards for sterile products

Certificate in Naturopathic ScienceThere is an increasing demand for medicines from traditional systems in developing as well as developed countries because of their being into existence since a very long time thereby enjoying the reputation of being both safe and efficacious. Naturopathy is a field of health care that works with, and not against standard allopathic health care providers, such as medical doctors. The philosophy of Naturopathy is to work with the body, to assist it in its natural ability to heal and maintain health. Treatments are natural and non-invasive and include herbal remedies, lifestyle changes, and dietary modifications and in some cases other complementary techniques including massage, acupuncture or aromatherapy.

Naturopathic practitioners focus on the work closely with the patient’s own unique set of symptoms, reactions and status. Natural health plays an important role for the holistic development of the personality. It is utmost important to have technical and scientific knowledge of all the components such as hydrotherapy, chromotherapy, diet therapy, magnet therapy etc. for promotion and preservation of health.

IGMPI Certified ModulesModule 1 : Human Anatomy and Physiology

Module 2 : Foundation of Naturopathy (Health, Nutrition & Yoga)

Module 3 : Indian System of MedicineModule 4 : Biochemistry

Future career prospects of Naturopathic ScienceThe ultimate goal of the Naturopath is to gradually and gently improve a patient’s health, enabling and motivating them to make lifestyle changes that they can maintain long term. Treatment is aimed at the illness causing symptoms, not at masking the individual symptoms themselves. The body is treated as a whole, the physical, emotional and mental aspects are all catered for. The naturopathy professional can opt different fields as per their choice, interest, expertise and knowledge. Some of the important broad disciplines where the naturopathic doctors can consume themselves inHospital and Healthcare Administration, Health Supervisor, Naturopathy Consultation as instructor, expert, specialist, etc.

IGMPI

Module 5 : Disease & Treatment by NaturopathyModule 6 : Extraction, Isolation and Analysis of PhytopharmaceuticalsModule 7 : Screening and Standardization of Herbal drugsModule 8 : AYUSH Regulatory Affairs

(Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)

Certificate programme in Quality by Design

The certificate covers all the statistical tools for QbD framework. The certificate features with industry specialists and experts facilitating quality implementation in various industries. QBD implementation can give manufacturers much more confidence in the robustness of their product, potentially increases the efficiency and quality of their development and manufacturing process as well as reduces profit leakages.

This certificate will provide insight into the key principles of QbD covering quality risk management and formal experimental design. The certificate is intended as continuing professional development (CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The certification will offer an excellent introduction for those less familiar with QbD and provide those with more experience with QbD, new ideas on how to further implement the QbD programme.

The case study based approach in certificate programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GMP professional in the domain. This certificate is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certificate having rigorous case studies based methodology throughout the duration. The training in QA & QC imparted by IGMPI is approved and certified by Quality Council of India, Government of India.

IGMPI Certified ModulesModule 1 : Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare

industries

Module 2 : Introduction to Quality by Design (QbD)

Module 3 : QbD Methodology and its Implementation

Module 4 : PAT Vision and Framework

Module 5 : PAT in Development, Manufacturing, Automation control system, Quality bydesign, Process validation etc.

Module 6 : Technology Identification and assessment

Future career prospects Across all types of industry, quality engineers are at work monitoring, testing and inspecting products to make sure they meet specified standards. Quality engineers test products to determine how long they will last, what part may break down first and how to improve product durability. The quality engineer also designs systems by which production quality can be checked in an ongoing process. In addition, quality engineers typically work with the production team to implement any new testing criteria or assembly methods they may have developed.

IGMPI

Certificate programme in Chemical Safety

The objective of the Chemical Safety programme by IGMPI is to impart training on how to identify chemical hazardous areas and where they exist around the facility. Personnel that will bring chemical hazards to the facility or engage in hazardous chemical work also need to complete the extended chemical safety training.

Chemical Safety is achieved by undertaking all activities involving chemicals in such a way as to ensure the safety of human health and the environment. It covers all chemicals, natural and manufactured, and the full range of exposure situations from the natural presence of chemicals in the environment to their extraction or synthesis, industrial production, transport use and disposal.

Chemical safety has many scientific and technical components. Among these are toxicology, ecotoxicology and the process of chemical risk assessment which requires a detailed knowledge of exposure and of biological effects.

Chemical hazards and toxic substances pose a wide range of health hazards (such as irritation, sensitization, and carcinogenicity) and physical hazards (such as flammability, corrosion, and explosibility). So we will learn here how to prevent ourselves from hazardous chemicals and what & which equipment should be used for various types of chemicals.

IGMPI Certified ModulesModule 1 : Chemical Hygiene and Safety

Module 2 : Handling of Hazardous Chemicals

Module 3 : Process safety Management (HAZOP Study & Risk Assessment)

Module 4 : Engineering, Installation, Commissioning, validation & Continuous improvement

Module 5 : International Guidelines for Chemical handling (WHO,EFHS, EHS, OSHA, FDA)

Module 6 : Chemical Safety for various Industries like Pharma, Food, Petrochemical, Pesticides,Fertilizers etc.

Module 7 : Various industrial case studies

Future career prospects Chemical Safety provides a strong focus on prevention from chemical hazards, toxic substances & physical hazards and use of green chemistry. You will learn the techniques for problem solving, risk analysis as well as managerial and practical application of knowledge to particular fact scenarios through a number of advice drafting exercises and also learn here how to prevent ourselves from hazardous chemicals and what & which equipment should be used for various types of chemicals.

Chemical Safety is important in extending benefits of R&D, Production and engineering to the society at a large, especially in developing countries.

IGMPI

Certificate programme in HVAC Systems Validation

Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of quality pharmaceutical products. Well-designed HVAC systems will also provide comfortable conditions for operators. HVAC systems account for as much as two-thirds of the energy usage in pharmaceutical facilities, system design and critical parameter selection for efficiency will be explored for all facility types. This course describes the HVAC simulation-based validation methodology, performance validation of HVAC systems, energy analysis of HVAC systems and other related factors involved with system simulations.

IGMPI Certified ModulesModule 1 : Introduction to Pharmaceuticals cGMPs (US FDA & WHO)

Module 2 : Pharmaceutical HVAC Rules and Design

Module 3 : HVAC Qualification (DQ, IQ, OQ, PQ) and Calcification

Module 4 : HVAC Commissioning and Testing

Module 5 : Validation of HVAC Systems

Module 6 : HVAC Audit and Inspection

Future career prospects Heating, Ventilation, Air Conditioning (HVAC) play an important role in ensuring the manufacture of quality pharmaceutical products. HVAC design engineers usually work for consulting or design companies. They focus on solving problems related to air quality issues, environmental issues or energy efficiency.

After completion of this course, professionals can work as HVAC validation specialist, HVAC validation engineer, HVAC validation consultant/analyst, HVAC Engineer.

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Certificate programme in WHO-GMPGMP is a critical concept in pharmaceutical industry. According to World Health Organization (WHO), Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled, according to quality standards. Main aim of this is to minimize risk involved in pharmaceutical manufacturing which is difficult to eliminate through testing the final product. Serious consequences may take place in absence of these standards such as License may get cancelled, product may be banned or charged for negligence/ non-compliance.

This Certificate programme bestows each interested working professional with long lasting benefits. This raises awareness among the key (responsible) people about the benefits of following GMPs and correct procedure to get GMP approval so as to introduce product in market successfully. This certificate is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certification having rigorous case studies based methodology throughout the duration.

IGMPI Certified ModulesModule 1 : Basic Principles of Pharmaceutical Good Manufacturing Practices

Module 2 : WHO-GMP

Module 3 : Certificate of Pharmaceutical Product (CoPP)

Module 4 : HVAC Systems Validation (WHO Perspective)

Module 5 : Risk-based approach to GMP

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IGMPI

As a prevalent leader in professional training, we offer outstanding training and professional guidance in Quality Management System (Medical Devices) which aids you to excel in your field and meet up with your exact requirement. The training programmes of IGMPI do not only focus on the theory but also give you the insight of real world. The coverage of course also includes the present day scenario of suppliers’ control and detail outlook to be considered in the: “Own Branding” and “Own labeling”. The students will also gain benefits from training by getting knowledge about the risk management system associated with outsourcing and supplier control.

This training is specially framed for providing the students with important qualities for performing internal audits on a company’s Quality management systems for Medical devices for the requirements of ISO 13485:2016 and to be responsible for overall development. This also covers the process of gaining CE marking certification under directive 93/42/EEC for all the medical devices which include: total joint implants 2005/50/EC and drug device combinations and associated directives 2003/32/EC. The certification programme also includes the review of technical document and site audits. The site audits will majorly analyze compliance with both ISO 13485:2003 and directive 93/42/EEC. This training course has been designed to indicate all the changes in regulatory front so that the manufacturer of the medical device can better understand the intricacies of updated EU IVDR and covers in vitro diagnostic medical devices and the requirement mentioned in it are for the manufacturers, Notified bodies and member state component authorities.

This training is going to assist your organization at compliance engineer, quality professional, training auditor and general levels. It helps in understanding of how the new regulatory norms are going to affect business, In addition is also guides consultant and the customer to write and revise the quality documents and consolidate technical files and provide guidance on quality and regulatory department. This course is going to guide you to head out for intricacies while making sure that the compliance with required regulations are met with top level of safety to patients and healthcare professional.

IGMPI

Certificate in Quality Management System for Medical Devices (ISO 13485)

Future career prospects of Certificate in Quality Management System (Medical Devices)Certificate in medical device will provide a horizon of knowledge to support you and your organization in the path of success. It will help you understand every step of assessment and procedures so that you fully understand the subject and standards that are applied across the whole supply chain and seeks to address he entire life cycle of Medical device.

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1) In depth knowledge of effectiveness of Quality Management System.

2) Overview of new regulations.

3) Practical application of USA, European Union and Indian medical device regulations.

4) Requirement of USA, European Union and Indian CE marking of medical devices

5) Requirement of USA, European Union and Indian marking of in vitro diagnostic medicaldevices

6) Technical documentation for Medical Device compliance in USA, European Union andIndia

7) Understand the requirement of ISO 13485:2016 -quality system requirement

8) Understand how to conduct internal audits

9) Detailed knowledge of ISO 13485:2016 audit and certification process

10)Develop knowledge and skills to prepare for third party audits against the requirement ofISO 13485:2016

11)Better understanding of internal audits, audits of supplier and third party audits ofmedical devices manufacturers.

The beneficial output of this programme includes:

EligibilityAll those working in the Pharmaceutical Industry or any sector of Healthcare industry or any other industry type (India or abroad) can apply for this short term programme. Life Science Graduate/ diploma holders are eligible for the course. Working professionals of any of the following industry types; Drugs manufacturing , Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Food manufacturing, Food Ingredient and Additive processing, Biotechnology or any related industry are highly encouraged to apply for the programme.

*For Natural Health the applicant must be Graduate in MBBS/ BHMS/ BAMS/ BUMS/ Bpharm/Mpharm/B.Sc. or M.Sc. in Nutrition & Dietetics and other related disciplines.

Programme DurationThe candidate is expected to complete the programme in 3 months.

Programme DeliverablesA comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

Assignments for all the programme modules for continuous evaluation and guidance.

Interactive or recorded lectures on all key areas of the programme giving all flexibility to the participants.

Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job. .

At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.

All learning and training delivery initiatives shall be conducted in English.

RegistrationThe registration dates for this programme run by the institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self regulated and self-paced performance to the participants.

Examination & CertificationIGMPI follows a credit system based on all all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

IGMPI

All the participants are expected to appear for online exam and are also obliged to submit assignments. After successful completion the participants will be awarded Certificate in GMP for Finished Pharmaceuticals & Good Manufacturing Practices In Manufacturing, Processing, Packing or Holding of Drugs / GMP In Manufacturing, Packing or Holding of Human Food / Food and Drug Regulatory Agencies/ Process Analytical Technology / Documentation in QA & QC Department / Registration of Drug and Dossier Preparation (CTD and eCTD submissions)/ Drug Registration (European market) / Drug Registration (GCC Countries) / Drug Registration (African countries) / Drug Registration (India)/ Drug Registration (US Market-ANDA,NDA etc.) / Preparation and submission of drug master file (DMF), Prescription to OTC switch, Computer System Validation, Pharmaceutical Validation, Computer Aided Drug Design (CADD), Good Clinical Practices (GCP), Analytical Testing and Equipment, Basics of Sterile Manufacturing, Natural Health, Quality by Design, Chemical Safety and HVAC Systems Validation and WHO-GMP. For all the above mentioned modules elaborate course material, assignment and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well.

Corporate RelationsIn recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc.

The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.

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Registration Number

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*Crossed DD or cheque should be in favour of “Institute of Good Manufacturing Practices India”payable at New Delhi. Please write your name and address at the back of DD/Cheque. Applicableexamination fee can be paid later as per the Institute's examination notification.

PERSONAL DATA

1. Name

(First Name) (Middle Names)(Last Name)

2. Gender Male Female

3. Date of BirthDD MM YYYY

4. Age : Years _____ Months_____

5. (a) Address for correspondence (in capital letters)

6. E-mail id :

7. Contact Telephone No. with STD Code Phone No. Mobile No.

Postal code/Zip code

Postal code/Zip code

(b) Permanent Address (in capital letters)

PLEASE NOTE:1. Please complete all the information accurately. Incomplete or false information may make your candidature null and void.2. Fill the form in CAPITAL LETTERS only. 3. The decision of the Institute will be final and binding on the applicants in all the matters relating to registration.4. For details of Program, please visit http://www.igmpiindia.org/ .5. You are required to enclose self-attested photocopies of all relevant testimonials along with the registration form.The completed registration form

should be sent by a registered post or couriered to the Director, IGMPI, H-119, H Block, Sector-63, Noida-201 307, Delhi National Capital Region(NCR), India, Phone: +91 8130924488, +91 8587838177, +91 120-4375280

6. You can send your signed application form and educational documents as scanned copies along with details of the online transaction to the email ID([email protected] ), in case of fee payment through net banking or through wire transfer.

Certificate Programme in : ........................................................................................................................................

Affix a recent coloured passport size photograph

APPLICATION FEE DETAILS*

AMOUNT Rs.

NEFT/PayU Ref. No.

DEMAND DRAFT/CHQ NO.

DATED

BANK

INSTITUTE OF GOOD MANUFACTURING PRACTICES INDIAGlobal accredited training & certification providerIGMPI

R

8. Nationality_________________________

WORK EXPERIENCE

10. Work Experience (if any)i) Total Work Experience ____years ____months and ____daysii) List all your work

From ToTotal

Completed Months

Days

Namethe

OrganizationDesignation Brief Job Profile

ACADEMIC QUALIFICATIONS

11. Pre-Bachelor's Degree Examination(s):

Std. School / Institution Board/ University Year completed Max. Marks

Total MarksObtained

% Marks Obtained

Class/Division

th10 / High School

th12 /

Intermediate/ Senior Secondary

9. Category (SC: Scheduled Caste; ST: Scheduled Tribe; OBC: Other Backward ClassesPH: Physically Handicapped; EWS: Economically Weaker Sections; Ex-servicemen;Defence Personnel; Attach copy of SC/ST/OBC, PH, EWS, Ex-servicemen,Defence Personnel certificate as applicable for 10% fee concession)

SC ST GENPH EWS OBC DefencePersonal

Ex- Service

men

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12. Bachelor's Degree Examination(s):

Degree Obtained

College/Institute University

Subject /Specialization

Year Date

From (DD/MM/YYYY) To (DD/MM/YYYY)

Marks considered for award of Class/Division in Bachelor's Degree

CGPA/ % Marks Obtained/ Grade

Degree Obtained



13. Post-Graduation Degree/Diploma (if any):

Year

From(DD/MM/YYYY)

To(DD/MM/YYYY)

SubjectMax.Marks

MarksObtained

% of Marks Obtained

Overall percentage of marks obtained

14. Professional qualification (if any):

Degree Obtained



Year

From(DD/MM/YYYY)

To(DD/MM/YYYY)

SubjectMax.Marks

MarksObtained

% of Marks Obtained

Overall percentage of marks obtained

DECLARATIONI have carefully filled up all the information and agree to abide by the decision of the Institute of Good Manufacturing Practices India, New Delhi authorities regarding my registration. I certify that the particulars given by me in this form are true to the best of my knowledge and belief.

Signature of ApplicantPlaceDate

IGMPI

IGMPI, H-119, H Block, Sector-63, Noida-201 307, Delhi National Capital Region (NCR), India Phone: +91 8130924488, +91 8587838177, +91 120-4375280, +91 120-2427175E mail: [email protected]

Delhi NCR

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