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Pharma Quality Management Systems online course Learn how to establish, monitor and improve a modern Pharmaceutical Quality Management System taking into account Good Manufacturing Practice (GMP) requirements and recent changes in GMP's requirements for Quality Systems. Learn how to establish, monitor and improve a modern Pharmaceutical Quality Management System taking into account Good Manufacturing Practice (GMP) requirements and recent changes in GMP’s requirements for Quality Systems. The Pharma Quality Management Systems online course is available online using a desktop pc, laptop, tablet or even a smartphone. It has been designed for busy Pharma professionals who want to fit short 15 to 30-minute chapters of learning into a hectic work schedule and cannot afford three, four or five days out of the office. Who will the course benefit? This Pharma Quality Management Systems course is aimed at busy professionals working in the Pharma industry who need to understand how a forward thinking modern Pharmaceutical Quality Management System can add real-value to their organisation. It is especially valuable for Quality Professionals, especially those working in Quality Assurance and Quality Improvement roles, as the course provides an eye-opening view of modern quality management thinking. Course overview: This Pharma Quality Management Systems course explains how to establish, manage, monitor and continually improve a forward thinking modern Pharmaceutical Quality Management System that adds real-value to your organisation. The course covers current principles on Pharmaceutical Quality Management Systems (PQMS) and includes the FDA’s “Guidance for Quality Systems” and ICH Q10 “Guidance on Pharmaceutical Quality Systems”. These guidelines explain the evolving nature of QMS thinking, with a focus on organisational effectiveness and efficiency rather than just product quality and GMP. Delegates will leave the Pharma Quality Management Systems online course with a clear understanding of how to successfully integrate GMP, ICH Q8, 9 & 10 and ISO 9000 principles into a compliant, effective, efficient and continually improving QMS for the whole business, as well as the role of Quality Personnel in re-shaping quality thinking to move with the times to meet today’s business challenges. www.inspiredpharma.com [email protected]

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Page 1: Phama QMS online course - inspiredpharma.com...h v ] ì ð W, o (t Ç } v o ] v u v h v ] ì ñ W, } Á }D ] v ] v Y µ o ] ÇD v P u v ^ Ç u •Z À ] Á } ( Z Ç u } (

Pharma Quality Management Systems online course

Learn how to establish, monitor and improve a modern Pharmaceutical Quality Management System taking into account

Good Manufacturing Practice (GMP) requirements and recent changes in GMP's requirements for Quality Systems.

Learn how to establish, monitor and improve a modern PharmaceuticalQuality Management System taking into account Good ManufacturingPractice (GMP) requirements and recent changes in GMP’s requirementsfor Quality Systems. The Pharma Quality Management Systems onlinecourse is available online using a desktop pc, laptop, tablet or even asmartphone. It has been designed for busy Pharma professionals who wantto fit short 15 to 30-minute chapters of learning into a hectic workschedule and cannot afford three, four or five days out of the office.Who will the course benefit?This Pharma Quality Management Systems courseis aimed at busy professionals working in thePharma industry who need to understand how aforward thinking modern Pharmaceutical QualityManagement System can add real-value to theirorganisation. It is especially valuable for QualityProfessionals, especially those working in QualityAssurance and Quality Improvement roles, as thecourse provides an eye-opening view of modernquality management thinking.Course overview:This Pharma Quality Management Systems course explains how toestablish, manage, monitor and continually improve a forward thinkingmodern Pharmaceutical Quality Management System that adds real-valueto your organisation. The course covers current principles onPharmaceutical Quality Management Systems (PQMS) and includes theFDA’s “Guidance for Quality Systems” and ICH Q10 “Guidance onPharmaceutical Quality Systems”. These guidelines explain the evolvingnature of QMS thinking, with a focus on organisational effectiveness andefficiency rather than just product quality and GMP.

Delegates will leave the Pharma Quality Management Systems onlinecourse with a clear understanding of how to successfully integrate GMP,ICH Q8, 9 & 10 and ISO 9000 principles into a compliant, effective, efficientand continually improving QMS for the whole business, as well as the roleof Quality Personnel in re-shaping quality thinking to move with the timesto meet today’s business challenges.

www.inspiredpharma.com [email protected]

Page 2: Phama QMS online course - inspiredpharma.com...h v ] ì ð W, o (t Ç } v o ] v u v h v ] ì ñ W, } Á }D ] v ] v Y µ o ] ÇD v P u v ^ Ç u •Z À ] Á } ( Z Ç u } (

Study Anytime Anywhere:This course is of about 25 hours duration – the equivalent to a 3-day classroom basedtraining course. The chapters of the course are each done in your own time. Workthrough the course materials when you like! The course is presented in short bite-sizechunks with assessments throughout to check your understanding. Tutor support isavailable via telephone and email. Once you are assigned to the Course you have 6months to complete the programme. To try a free Taster course including 3 Chapters ofthe programme visit our website

Course contents:Unit 01: The Evolution of Quality Management Systems• Introduction to the course• The concept of Quality and Quality Definitions• The concept of Quality Management System thinking• The evolution of Quality Management System thinking• Good Manufacturing Practice – EU and USA GMP• Pharmaceutical principles of QA, GMP and QC• Traditional GMP and modern QMS thinking

www.inspiredpharma.com [email protected]

Unit 02: How to Design a Quality Management System• The design criteria for an effective QMS• Comparison of ISO 9001 and GMP• Pharmaceutical QMS evolution• The FDA’s Quality System Model & ICH Q8, 9 & 10• Documentation systems, documents and record keeping• Organisational structures, reporting relationships and review• The design, selection and qualification of premises, equipment, utilities and

services• The concepts associated with risk management• Additional guidance for those starting a new QMS

Unit 03: How to Design a Quality Management System• Assigning roles and responsibilities• The roles of the Heads of Production & QC and the Qualified Person• The role of QA and their interaction with other departments• The roles and responsibilities of Top Management• Training and evaluation• The skills and competencies needed to provide effective GMP training

Unit 04: Half Way online assessment

Unit 05: How to Maintain a Quality Management System• Review of the system so far• Purchasing and supplier qualification• Supply chain, materials control, brokers, distributors and repackagers• Outsourcing and technical agreements• Production planning, scheduling and inventory control• Deviations and change control• Calibration and preventive maintenance

See next page for details of Chapters 6-9

Pharma Quality Management Systems online course

Page 3: Phama QMS online course - inspiredpharma.com...h v ] ì ð W, o (t Ç } v o ] v u v h v ] ì ñ W, } Á }D ] v ] v Y µ o ] ÇD v P u v ^ Ç u •Z À ] Á } ( Z Ç u } (

Course contents (continued):

Unit 06: How to Evaluate a Quality Management System• Annual Product Quality Reviews• Economic and statistical indicators• Staff Appraisals and Performance Management• Management ReviewAuditing and self-inspection• The collection and analysis of data

www.inspiredpharma.com [email protected]

Unit 07: How to Improve a Quality Management System• Customer complaints and satisfaction monitoring• Correction, Corrective Action and Preventive Action• Quality metrics – GMP and beyond• The Process Approach• Process based auditing• Internal customer focus• Interpersonal skills and required behaviours

Unit 08: Miscellaneous• Course summary• References and useful web-sites

Unit 09: Final online assessment

Pharma Quality Management Systems online course

Experts involved in the creation of this course:Peter LavisArguably the finest Quality Management Systems tutor in thebusiness, Peter’s enthusiasm for quality system thinking and hisoutstanding training abilities have gained him international praiseand appeal. Peter is a leading quality management systemsauditor and encourages auditors to think outside the “GMP box”.

Dominic ParryDominic has worked in the pharmaceutical industry since 1992,and is a leading pharmaceutical quality management specialist.He is generally recognised as one of the leading GMP trainers inthe UK and brings an enormous amount of interest, enthusiasmand fun into the training he presents.Ron OrmeRon has been involved in the learning and development industryfor over 20 years. He is a Fellow of the Learning and PerformanceInstitute and in 2004 received the LPI ‘Colin Corder’ award foroutstanding services to the training industry. He is the architectbehind our website and our learning platform and also developsthe web-based learning courses that we now offer to supportmany of our learning programmes. In addition, he also providesgeneral business support on strategy and sales and marketing.

Page 4: Phama QMS online course - inspiredpharma.com...h v ] ì ð W, o (t Ç } v o ] v u v h v ] ì ñ W, } Á }D ] v ] v Y µ o ] ÇD v P u v ^ Ç u •Z À ] Á } ( Z Ç u } (

Why choose this course?

The benefits of this programme:• Designed for busy Pharma professionals who want to fit

short 15 to 30-minute chapters of learning into a hecticwork schedule and cannot afford three, four or fivedays out of the office

• Course notes (delegate pack) available to print andkeep.

• Do the course when you like – no need to attend onspecific days.

• Convenience – access anytime at home or at work. Allyou need is internet access and a computer, iPad,iPhone or tablet.

• Assessments throughout the course to checkunderstanding.

• Tutors contactable via phone or email (UK office hours).• The course fee is the price you pay – no hidden or extra

costs of travel, accommodation and meals.• Why not give us a try? Others have and were really

impressed – see below. To try a free Taster courseincluding 3 Chapters of the programme visit ourwebsite.

Course feedback:This highly rated course enjoys very high completion rates. Delegatefeedback is outstanding, with a selection of feedback shown below:

I will definitely recommend it for other colleaguesQA Manager, GLAXOSMITHKLINEI liked the course very muchQA Manager, ASTELLASThis course is very helpful to understand overall QMS especially if someone hasnever worked in Quality Assurance department. Since I want to switch my careerfrom QC to QA, the course has helped me a lot. My knowledge andunderstanding about Quality, Quality management system, and other importantaspects relating to functionality of pharmaceutical industry have increased. Iwould recommend this course to othersSheetal PatelThe whole course has been extremely well structured and I have enjoyed taking itPharmaceutical ConsultantThe course was very useful to have a better understanding of the QMS of mycompany. I would highly recommend it!Salvatore L – from our Reviews.io website

Pharma Quality Management Systems online course

www.inspiredpharma.com [email protected]

Page 5: Phama QMS online course - inspiredpharma.com...h v ] ì ð W, o (t Ç } v o ] v u v h v ] ì ñ W, } Á }D ] v ] v Y µ o ] ÇD v P u v ^ Ç u •Z À ] Á } ( Z Ç u } (

www.inspiredpharma.com [email protected]

Study Anytime Anywhere:Access the course anytime at home and at work . All you need is internet access anda computer, iPad, iPhone or tablet. This course is of about 25 hours duration – theequivalent to a 3-day classroom based training course. The chapters of the course areeach done in your own time. Work through the course materials when you like! Thecourse is presented in short bite-size chunks with assessments throughout to checkyour understanding. Tutor support is available via telephone and email. Once you areassigned to the Course you have 6 months to complete the programme.

Contact us:Inspired Pharma Training Limited, 1210 Parkview, Arlington Business Park, Theale,Reading, Berkshire, RG7 4TY, UK Telephone: + 44 1635 866699Registered in England and Wales Company Registration Number 7125386

Costs:The cost for access to the course is £795.

VAT will be charged for delegates doing the coursewho are based in the UK. However delegates fromoutside the UK but within the European Union (EU)will not be charged VAT if they supply their owncompany’s national VAT number when booking. VATwill not be charged for any delegates from outsidethe EU.

The cost includes:• Access to the on-line learning platform for 12

months• Course notes containing copies of slides, notes

and handouts.• Tutor support provided.• A course certificate on completion of the

course.

Payment and cancellations:

Once full payment has been made we will send you your login details.

To ensure this style of learning is right for you we recommend you try a free Tastercourse including 3 Chapters of the programme - visit our website to access theseTaster courses.

Once you access the course no refunds will be made.

Please book viaour website

www.inspiredpharma.com

Pharma Quality Management Systems online course


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