reduced sampling / reduced testing - eca academy - gmp...
TRANSCRIPT
25-26 February 2019, Budapest, Hungary
SPEAKERS:
Emerich GrassingerAenova Group - Haupt Pharma Wülfing GmbH, Germany
Dr Matthias HeuermannNRW Centre for Health (LZG.NRW), Germany
Dr Gerald KindermannF. Hoffmann-La Roche, Switzerland
Dr Michael MöhlenValneva Austria GmbH, Austria
Dr Bernd RengerBernd Renger Consulting, Germany
Dr Martin WeschWesch & Buchenroth, Law Office, Germany
This education course is recognised for the ECA GMP Certification Programme „Certified Quality Control Manager“. Please find details at www.gmp-certification.euWA/12032018
Reduced Sampling / Reduced TestingcGMP compliant Sampling and Testing of Starting and Packaging Materials – how to Meet EU and FDA Requirements and safe Costs in QA/QC
LEARNING GOALS:
� Regulatory Requirements for Sampling � Design and Qualification of Sampling Areas � Supplier Qualification as an Important Prerequisite for Reduced Sampling / Reduced Testing:
– Supplier Audits – Quality Agreements – Specifications / Monographs / Supplier CoA
� How to Define and Optimise Sampling and Testing Procedures for
– APIs – Excipients – Primary Packaging Materials – Secondary Packaging Materials
� Options for Reduced Sampling � Options for Reduced Testing � How to Deal with Multicompendial Testing?
Objectives
The aim of this course is to demonstrate the process of the qualification of starting materials (APIs and excipi-ents) and packaging materials (primary and secondary) and to define the prerequisites for implementing a sys-tem for reduced sampling and reduced testing for these products. This system has to be in compliance with the actual GMP requirements in Europe and in the US, though. Case Studies will show how to define and opti-mise sampling and testing procedures and you will dis-cuss further details in a parallel session with 3 workshops.
Background
Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the materials are released only after their quality was judged as satisfactory.
According to the revised Chapter 5 – Production – of the EU GMP Guide in operation since March 2015, the selec-tion, qualification, approval and maintenance of suppli-ers has to be documented and the level of control has to be proportionate to the potential risks posed by the indi-vidual materials. Manufacturers of medicinal products are responsible for testing the starting and packaging ma-terials as described in the marketing authorisation dos-sier. However, it is explicitly accepted to outsource these testing activities, if the following requirements are ful-filled:
a) Distribution controls (transport, wholesaling, storage and delivery) to ensure the maintenance of the quality characteristics of the starting materials
b) Audits performed at appropriate intervals at the sites carrying out the testing
c) A certificate of analysis signed by a designated person with appropriate qualifications and experience
d) Significant experience in dealing with the starting material manufacturer (“history of compliance”)
e) Full analyses that are performed regularly by the me-dicinal product manufacturer or a contract laboratory acting on behalf of the manufacturer to compare the re-sults with the supplier’s certificate of analysis.
It is the aim of this GMP Education Course to show how these requirements can be put into practice.
Other focus areas of this course are the regulatory re-quirements for sampling, the design and qualification of sampling areas and the handling of varying specifications in the different pharmacopoeias for identical APIs and excipients used for finished drug products dedicated for the markets in Europe, in the US, and in Japan.
Must different tests be conducted according to EP, USP, and JP, respectively?
The course programme will be completed by a lawyer’s presentation about the legal and contractual liability of suppliers for defect products.
Target Audience
This GMP Education Course is directed at all those em-ployees from quality control units in the pharmaceutical industry (including heads of quality control and labora-tory managers) who are competent or responsible for sampling, testing and release of starting materials (APIs and excipients) and packaging materials (primary and secondary). This course is also of interest to personnel from quality assurance and to those employees from API, excipient or packaging material suppliers who want to inform themselves about the requirements of the phar-maceutical industry on the testing of these materials.
Programme
Regulatory Requirements for Sampling Procedures � API and finished goods sampling � Regulatory requirements
– EU GMP Part 1, Chapters 4, 5, 6 – EU GMP Part 2, Chapter 7 – EU GMP Annex 8 – EU GMP Annex 19
� Other regulations – US / FDA Requirements – WHO - PIC/S - ISO 2859-1 (former Military Standard)
� Supplier qualification and audits – Reduced testing
Design and Qualification of Sampling Areas for Incoming Goods Products
� Sampling area for raw materials, APIs and excipients � Layout and design of premises and equipment � “Cleanroom”-like classification? � What are the appropriate environmental requirements for sampling areas?
� How to qualify and maintain sampling areas? � Is a change of pallets/removal of cart boxes required? � Are expectations increasing? - Lessons learned during inspections
Supplier Qualification and Supply Chain Traceability: an important Prerequisite for Reduced Sampling and Reduced Testing
� Prerequisites � Qualification of packaging materials � Qualification of APIs and excipients � Supplier qualification / Supplier audits � Quality Agreements � Specifications / Pharmacopoeial monographs / Supplier CoA
� Complaint Handling
Reduced Sampling / Reduced Testing
25-26 February 2019, Budapest, Hungary
Sampling and Documentation to make the Supplier liable for Defect Products
� Legal and Contractual Liability � Definition of a Product Defect � Express Warranty � Admissible Evidence � Insurability
Case Study I: How to Define Inspection Procedures for Packaging Materials (Primary and Secondary) in the Incoming Goods Control
� Sampling Plans for printed packaging materials, glass containers, plastic containers, etc.
� AQL (Acceptable Quality Level) � Tests required according to Ph.Eur. / USP � Options for reduced sampling � Options for reduced testing � Skip lot testing
Case Study II: How to Define and Optimise Sampling and Testing Procedures for APIs and Excipients in the Incoming Goods Control
� Sampling of APIs and excipients � Risk assessment and rational for different sampling plans and sampling procedures
� Options for reduced ID testing � Options for reducing analytical costs (economic order size and accepting CoA from suppliers)
� Optimization of ID testing using NIR/RAMAN
Parallel Sessions: Working on specific Tasks
1. Strategies/Prerequisites for Reduced Testing / Reduced SamplingThe aim of this workshop is to evaluate in small discussion groups how the opportunities and requirements of EU GMP Chapter 5, Annex 8 and 21 CFR Part 211 should be implemented in QA / QC.Moderator: Dr Bernd Renger
2. Reduced Testing / Reduced Sampling for APIs / ExcipientsParticipants will discuss and calculate benefits of different measures in small groups. Scenarios of different materials / suppliers / qualification status, use of NIR/RAMAN for iden-tity testing and optimization of the order size to reduce testing effort will be evaluated including their impact on the sampling and testing plans for APIs and excipients.Moderator: Emerich Grassinger
3. Reduced Testing / Reduced Sampling for Primary and Secondary Packaging MaterialsParticipants will discuss in small groups scenarios of different materials / suppliers / qualification status / etc. and their impact on the sampling and testing plans with regard to reduced sampling and reduced testing for packaging.Moderator: Dr Gerald Kindermann
You will be able to attend 2 of these parallel sessions. Please choose the ones you would like to attend when you register for this Course.
How to Deal with Divergent Compendial Method Requirements
� ICH QB4 and the Pharmacopoeial Discussion Group � Divergent and conflicting pharmacopoeial requirements
� CDER’s MAPP 5310.7 “Acceptability of Standards from Alternative Compendia”
� How to proceed in case of missing harmonization? � How to proof equivalence?
Speakers
Emerich GrassingerAenova Group - Haupt Pharma Wülfing GmbH, GermanyEmerich Grassinger works since 1995 in various positions for the pharmaceutical industry. 2002-2010 he headed several labs within Boehringer Ingelheim and was
there also responsible for the Raw Material laboratory in which the testing and release of the APIs and Excipients was carried out. He led several improvement projects throughout the supply chain involving the raw material releasing process. In 2010, he joined Haupt Pharma Wül-fing, where he is responsible for Quality Control and im-plements various Lean Lab instruments within the Ae-nova Group.
Dr Matthias HeuermannNRW Centre for Health (LZG.NRW), Münster, GermanySince 2004 Dr Heuermann is employed as head of the Official Medicines Control Laboratory (OMCL), today within the NRW Centre for Health of the federal state
North Rhine-Westphalia. He studied pharmacy and gained his PhD thesis at the University of Münster, Ger-many. Since 1995 Dr Heuermann is involved in national and international GMP inspections with a focus on QC laboratories and QA systems.
Dr Gerald KindermannF. Hoffmann-La Roche, Basel, SwitzerlandDr Gerald Kindermann is Product Quality Manager at the Global Quality Group at Roche working on quality systems. Before that he was Group Leader Quality Control and Quality Manager for the Supply Center.
Dr Michael MöhlenValneva Austria GmbH, Vienna, AustriaDr Möhlen is the Head of Technical Operations at Valneva Austria GmbH in Vienna and responsible for industrialisa-tion of Vaccine candidates. This includes oversight as well to Quality Control and
Clinical Serology. Until 2009 Dr Möhlen held various management positions in the Quality Control arena with Chiron and later Novartis Vaccines, including responsi-bility for raw material sampling and testing.
Dr Bernd RengerBernd Renger Consulting, GermanyDr Bernd Renger was a member of the European Compliance Academy (ECA) Advisory Board and Immediate Past Chair of the European QP Association. Since 2011 he is running his own consultancy
business. Before that he was VP of Quality Control at Vetter Pharma-Fertigung. He started his career in 1977 at Hoechst AG as a research and development chemist. Since then, he has held several quality management positions at Mundipharma, Byk Gulden (now Takeda) and Baxter BioScience in Vienna.
Dr Martin WeschWesch & Buchenroth, Law Office, GermanyDr. Martin Wesch is a lawyer specialised in medical and industrial law and working for the Stuttgart-based firm of lawyers Wesch & Buchenroth, which he founded in 2001. Since April 2002, he has been teaching
industrial law at the University of Stuttgart. He is author of several publications, both in journals and books, to legal demands on quality assurance in manufacturing pharmaceuticals. In 2007 he received the Wallhaeusser Prize for publications in that field from Concept Heidel-berg.
Social Event
On the evening of the first course day you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
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Easy Registration
Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 Heidelberg, Germany
Reservation Form:+ 49 6221 84 44 34 @ e-mail:
[email protected] Internet:www.gmp-compliance.org
Date
Monday 25 February 2019, 09.00 - 18.00 h (Registration and coffee 08.30 – 09.00 h)Tuesday, 26 February 2019, 08.30 - 15.30 h
Venue
Hilton Budapest CityVáci út 1-3.1062 Budapest, HungaryPhone +36 1 288 5500Email [email protected]
Fees (per delegate plus VAT)
ECA Members € 1,490APIC Members € 1,590Non-ECA Members € 1,690EU GMP Inspectorates € 845
The course fee is payable in advance after receipt of in-voice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Would you like to safe money?
If you register for ECA’s Education Course “Analytical In-strument Qualification” from 27 February to 1 March 2019 at the same time, you will receive a 350 € discount. This is not valid for EU GMP Inspectorates.
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the event. Please use this form for your room reservation to receive the specially negotiated rate for the duration of your stay. Reservation should be made directly with the hotel. Early reservation is recommended.
Registration
Via the attached reservation form, by e-mail or by fax mes-sage. Or you register online at www.gmp-compliance.org.
Conference language
The official conference language will be English.
Organisation and Contact
ECA has entrusted Concept Heidelberg with the organisation of this event.CONCEPT HEIDELBERGP.O. Box 10 17 64D-69007 Heidelberg, GermanyPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 [email protected]
For questions regarding content please contact:Dr Günter Brendelberger (Operations Director) at phone +49-62 21 / 84 44 40, or by e-mail at [email protected].
For questions regarding reservation, hotel, organisation etc. please contact:Mr Rouwen Schopka (Organisation Manager) at phone +49-62 21 / 84 44 13, or by e-mail at [email protected].
ECA CourseAnalytical Instrument Qualification
27 February - 1 March 2019, Budapest, Hungary
From 27 February to 1 March 2019, i.e. on Wednesday to Friday of the same week, the ECA Education Course Analytical Instrument Qualification will take place in the same hotel in Budapest. Topics to be covered will include:
� Regulatory Aspects of Instrument Qualification and USP <1058>
� Calibration Management � Risk Assessment in Analytical Laboratories � Qualification of GC Instruments � Qualification of RAMAN, NIR, and FT-IR � Balances and Weighing Processes � Volumetric Apparatus � Computer Validation � HPLC / Chromatography Data Systems � Validation of Excel Spreadsheets � Data Integrity Challenges in Calibration and Qualification
Interactive Workshops will also be part of this course.Further information about this Education Course can be
received at www.gmp-compliance.org.
Register simultaneously for both courses and receive a 350 € discount (not valid for EU GMP Inspectorates).
General terms and conditionsIf you cannot attend the conference you have two options:1. We are happy to welcome a substitute col-league at any time.2. If you have to cancel entirely we must charge the following processing fees: Cancellation - until 2 weeks prior to the conference 10 %,- until 1 weeks prior to the conference 50 %- within 1 week prior to the conference 100 %.CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event.
If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. CONCEPT HEIDELBERGwill not be responsible for discount airfare penalties or other costs incurred due to a cancellation.Terms of payment: Payable without deductions within 10 days after receipt of invoice. Important: This is a binding registration and above fees are due in case of cancellation or non-appearance. If you cannot take part, you have to inform us in writing.
The cancellation fee will then be calculated ac-cording to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee, even if you have not made the payment yet. Only after we have received your payment, you are entitled to participate in the conference (receipt of payment will not be confirmed)! (As of January 2012).
German law shall apply. Court of jurisdiction is Heidelberg.
Privacy Policy: By registering for this event, I accept the processing of my Personal Data. Concept Heidelberg will use my data for the pro-cessing of this order, for which I hereby declare to agree that my personal data is stored and pro-cessed. Concept Heidelberg will only send me information in relation with this order or similar ones. My personal data will not be disclosed to third parties (see also the privacy policy at http://www.gmp-compliance.org/eca_privacy.html). I note that I can ask for the modification, correction or deletion of my data at any time via the contact form on this website.
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Image: BÜCHIParticipate in 4 Workshops!
SPEAKERS:
Jörg KastenschmidtMerck, Germany
Philip LienbacherShire, Austria
Roland MikscheMiRo Consulting Vienna, Austria
WA/11042018 This education course is recognised for the ECA GMP Certification Programme „Certified Quality Control Manager“. Please find details at www.gmp-certification.eu
LEARNING OBJECTIVES:
� Regulatory Aspects of Analytical Instrument Qualification � USP General Chapter <1058> - Analytical Instrument Qualification � Risk Assessment in Analytical Laboratories � Calibration Management � Balances and Weighing Processes � Practical Examples of Analytical Instrument Qualification and Calibration: - Spectroscopic Instruments and Detectors (UV/VIS, IR, NIR, NMR, etc.) - pH Measuring Instruments - HPLC / GC - RAMAN / NIR / FT-IR - Thermometers and Hygrometers
� Computer Validation in Analytical Laboratories � Validation of Excel® Spreadsheets � Data Integrity Challenges in Calibration and Qualification
Analytical Instrument Qualification
27 February – 1 March 2019, Budapest, Hungary
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
Analytical Instrument Qualification 27 February – 1 March 2019, Budapest, Hungary
Learning Goals
Calibration and qualification of equipment are key require-ments in GMP guidelines (EU GMP Guide, Annex 15 to EU GMP Guide, and FDA’s Code of Federal Regulations, 21 CFR Part 211). These requirements also apply to instruments and systems in analytical laboratories of the pharmaceutical in-dustry. Besides calibration and qualification, the validation of computerised systems is another key issue. The software components associated with the instruments and systems must be shown to be fit for their intended purpose. Com-puter validation requirements and guidances for the phar-maceutical industry are laid down, amongst others, by the EU (Annex 11 to EU GMP Guide, the PIC/S (Good Practices for Computerised Systems in Regulated “GXP” Environ-ments”), GAMP® (Good Automated Manufacturing Prac-tice), and FDA’s Part 11.
The United States Pharmacopoeia (USP) has adopted the General Chapter <1058>, Analytical Instrument Qualifica-tion, in 2008. This General Chapter <1058> has been up-dated in 2017.
The objective of this course is to provide the participants with an overview of the regulatory requirements on the qualification of analytical equipment and the software vali-dation of computerised systems and to give practical advice on successful approaches to calibration, qualification, vali-dation, and routine monitoring of instrumentation and sys-tems. Key requirements of the important USP General Chapter <1058> will be presented and discussed.
The course will cover the following instruments and systems amongst others:
� UV/VIS Spectrophotometers,, Disintegration and Dissolution)
� Balances and Masses � pH � RAMAN / NIR / FT-IR � HPLC and GC � Chromatographic Data Systems � Excel® - Spreadsheets
Interactive workshops will allow the participants to discuss key areas of interest and to exchange practical experiences.
Target Group
This GMP Education Course will be of practical value to scientists and engineers in analytical laboratories and con-tract laboratories in an FDA-/GMP-regulated environment who are responsible for the calibration and qualification of their laboratory equipment and for the validation of the computerised systems used in their laboratories.
Programme
Regulatory Aspects of Analytical Instrument Qualification
� Overview about legislations including - Europe: EU GMP Guide - Annex 15 - US: CFR, USP - National: German ZLG quality manual
� Other relevant documents (Interpretation documents) and authority expectations
� Overview about Qualification steps � Equipment life cycle
USP General Chapter <1058> - Analytical Instrument Qualification
� Key recommendations of this USP General Chapter � Qualification steps: which activities should be performed in each phase?
� Roles and responsibilities for the user, Quality Assurance and for the manufacturer/vendor
� Software validation, Change Control & Documentation
� Instrument categories
General Aspects of Calibration � Overview: regulatory aspects / requirements � Definitions / terminology � Concepts and documentation � Handling OOC (Out of Calibration)
WORKSHOP ITopic: Apparatus & Instruments List Case Study / Risk Categorisation According to USP <1058>MODERATOR: Joerg Kastenschmidt
Risk Assessment in Analytical Laboratories � Scaring examples � Advantages of minimizing risk � Definition and regulation (EU GMP Part 3 - Quality Risk Management, etc.).
� Approach, applicability, documentation, approvals � FMEA (Failure Mode and Effect Analysis) � HACCP (Hazard Analysis and Critical Control Points) � ISHIKAWA DIAGRAM (Fishbone) � FTA (Fault Tree Analysis) � Risk assessment of changes
WORKSHOP IITopic: Qualification / Risk Analysis of pH Measuring InstrumentsMODERATOR: Roland Miksche
Calibration Management � Parts of a calibration management system
- Procedure(s) - Documentation - Calibration standards - Calibration management software
� Calibration interval adjustment � OOC/OOT evaluation � What can go wrong and how to avoid it
Data Integrity Challenges in Calibration and Qualification
� Relevant Guidelines � Documentation- & Data-management-Systems in the Pharma/Device industry
� Achieving data integrity: Creating a culture of quality around document- and data management
� What can go wrong and how to avoid it!
Qualification of Specific Instruments and Systems � Requirements according to USP � Traceability of standards � Practical approaches to qualification and calibration of
- UV-Visible - Dissolution - Disintegration - Osmometer - Particulate Matter - Turbidity - Dishwasher
Qualification of GC Instruments � Warning Letters (483) and Findings � Technical Overview, Applications � From Vendor to Decommissioning: AIQ-Lifecycle � System Suitability Test � Periodic Review (Checklist)
Balances and Weighing Processes � Weighing basics � Environmental influences on weighing � Practical aspect on weighing � Requirements acc. to USP <41> and <1251> � Qualification and calibration of balances � Weights (OIML R111-1)
WORKSHOP IIITopic: BalancesMODERATOR: Joerg Kastenschmidt
Qualification of RAMAN / NIR / FT-IR � Quick overview RAMAN / NIR / FT-IR & benefits � Qualification: What are the specifics? � Potential difficulties
Volumetric Apparatus (Pipets, Dispensers, etc.) � Selection of suitable apparatuses � Qualification / calibration � Volumetric laboratory glassware
Assurance of Controlled Temperature and Humidity � Thermometers and thermometry � Hygrometers and hygrometry � Qualification approaches to
- Refrigerators and freezers - Climatic storage rooms and incubators - Ovens & muffle furnaces - Water baths
General Aspects of Computer Validation in Analytical Laboratories
� PIC/S Guidance Good Practices for Computerised Systems in Regulated “GXP” Environments
� New EU GMP Annex 11 Computerised Systems � Requirements of 21 CFR Part 11 � Life cycle concept � Integration of equipment qualification and computer validation
� Retrospective validation
HPLC / Chromatography Data Systems – Integrated Qualification and Validation
� Master Validation Plan (MVP) � Assessments (Risk to Quality, 21 CFR Part 11) � User Requirement Specification (URS) � Function- and Design Specification (FS/DS) � Risk Analysis (RA) � Validation Protocol (VP) � Test Cases (Deviations, Incidents, Changes) � Final Report (FR) � Standard Operation Procedures (SOP) � Forms (User Access, Monitoring, Updates...) � Service Contracts, Helpdesk, Logbook
Validation of Excel® Spreadsheets � Areas of Usage � Known Errors and Findings � Categorisation according GAMP � Lifecycle Phases and Documentation:
- Requirements Phase - Definition, Build Phase - Testing Phase - Release - Changes, Decommissioning
� Literature (Regulations, Guidances)
WORKSHOP IVTopic: Validation of Excel Spreadsheets(Categorisation, responsibilities, required docu-ments, contents of documents, testing, versioning, data handling)MODERATOR: Roland Miksche
Speakers
JOERG KASTENSCHMIDTMerck, Darmstadt, GermanyJörg Kastenschmidt is an engineer of chemi-cal and bio-technology. He started his career in 2001 as project engineer at the PHAST GmbH in Homburg/Saar. After work-
ing in the GMP processes unit within the pharmaceutical analytical development at Merck for 10 years, he joined the development QA in 2016, where amongst other things he is responsible for qualification of analytical instruments, production equipment / facilities and validation of IT-systems.
PHILIP LIENBACHER, Shire, Vienna, AustriaPhilip Lienbacher started his career within Shire (previously Baxter/Baxalta) in 2008 in Vienna. Since then he held a variety of roles inside quality. In 2014, he accepted the posi-
tion of Manager Global Material Lifecycle Management Systems and is responsible for a team of process experts and project managers. His responsibility includes the global ownership for Receiving & Inspection as well as the general testing- and method deployment-strategy in the company.
ROLAND MIKSCHEMiRo Consulting Vienna, AustriaAfter more than 15 years driving CSV, data integrity and all global IT projects within the Quality Assurance Department of Shire, he implemented EBM, an electronic batch
management system, at Shire and afterwards, as Senior Consultant of HGP Pharma Consulting, at a customer in Germany. He made his final exam in biochemistry in Vi-enna, Austria, worked as analyst in accredited laborato-ries and as a sales and service expert for scientific equip-ment.
Social Event
In the evening of the first course day all participants and speakers are invited to a guided sight-seeing tour of the city of Budapest, followed by a dinner, where the topics of the course can be further discussed in a relaxed at-mosphere.
Date
Wednesday, 27 February 2019, 9.00 h - 18.00 h(Registration and coffee 08.30 h - 9.00 h)Thursday, 28 February 2019, 08.30 h - 18.00 hFriday, 1 March 2019, 08.30 h - 16.00 h
Venue
Hilton Budapest CityVáci út 1-3.1062 Budapest, HungaryPhone +36 1 288 5500Email [email protected]
Fees (per delegate plus VAT)
ECA Members € 1,790APIC Members € 1,890Non-ECA Members € 1,990EU GMP Inspectorates € 995The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on all three days and all refresh-ments. VAT is reclaimable.
Would you like to safe money?
If you register for ECA’s Education Course Reduced Sam-pling / Reduced Testing from 25 -26 February 2019 at the same time, you will receive a 350 EUR discount. This is not valid for EU GMP Inspectorates.
Accommodation
Concept Heidelberg has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form with all further information when you have registered for the event. Reservation should be made directly with the hotel. Early reservation is recommended.
Registration
Via the attached reservation form, by e-mail or by fax mes-sage. Or you register online at www.gmp-compliance.org.
Conference language
The official conference language will be English.
Organisation and Contact
CONCEPT HEIDELBERGP.O. Box 10 17 64, D-69007 Heidelberg, GermanyPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 34E-mail: [email protected]
For questions regarding content:Dr Günter Brendelberger (Operations Director) at +49-(0)62 21 84 44 40, or per e-mail at [email protected].
For questions regarding reservation, hotel, organisation etc.: Mr Rouwen Schopka (Organisation Manager) at+49 (06221/84 44 13, or per e-mail [email protected]
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Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany
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ECA Education CourseReduced Sampling/Reduced Testing25-26 February 2019, Budapest, Hungary
Directly before this ECA Education Course Analytical Instrument Qualification on 25-26 Februray 2019 there will be the ECA Education Course Reduced Sampling/Reduced Testing with these topics:
� Regulatory Requirements for Sampling Procedures � Design and Qualification of Sampling Areas for In-coming Goods Products
� Supplier Qualification: an important Prerequisite for Reduced Sampling and Reduced Testing
� How to Deal with Divergent Compendial Method Requirements (EP, USP, JP)
� Case Study I: How to Define Inspection Procedures for Packaging Materials (Primary and Secondary) in the Incoming Goods Control
� Case Study II: How to Define and Optimise Sampling and Testing Procedures for APIs and Excipients in the Incoming Goods Control
� Sampling and Documentation to make the Supplier liable for Defect Products
Further details will be discussed in a parallel session with 3 workshops.
Further information about this course can be received at www.gmp-compliance.org.
Participants who register simultaneously for both cours-es will receive a 350 € discount (not valid for EU GMP Inspectorates).