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New Revised EU GMP Annex 11
New Revised EU GMP Annex 11
New Revised EU GMP Annex 11
The EC has announced a new revision of EU GMP Annex 11 Computerised Systems. There are also associated changes to EU GMP Chapter 4 Documentation. Annex 11 has been revised in response to the increased use of computerised systems and the increased complexity of these systems. The Annex defines EU requirements for computerised systems, and applies to all forms of computerised systems used as part of GMP regulated activities. This is a major revision, which has a significant impact on all GMP regulated companies.

Significant aspects include revised and enhanced requirements covering quality risk management, system inventory, supplier assessment, periodic evaluation, and many topics covering system operation. At the conclusion of this session, participants will be able to:
  • Understand the changes to Annex 11
  • Understand why these changes were required
  • Understand what industry needs to do to comply
  • Presenter Biographies

    Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field. He is currently assisting the FDA with its re-examination of 21 CFR Part 11, and is a member of the team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He is the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He has received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE’s GAMP®5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Council, GAMP Editorial Board, and the GAMP Europe Steering Committee. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated healthcare industries. Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry.

    Chris Clark BSc, MCQI, Head of Quality Compliance, NAPP Pharmaceuticals, has 30+ years experience of QC/QA within the pharmaceutical/healthcare industries. Currently holds a position as Head of Quality Compliance at NAPP Pharmaceuticals includes responsibility for the management of the Production and Research quality systems ensuring compliance to current GMP’s, GCP’s and GLP’s.Involved in the implementation/validation of many types of pharmaceutical systems including Purified Water, Air Handling, Manufacturing/Packaging equipment and Facilities. Specialised experience of implementation of both large and small computerised systems (MRPII, EDMS, Clinical Trials data management). Also undertakes IT services audits of Contract Research Organisations and Investigator Sites. Current Chair of the GAMP® Editorial Review Board, past Chair of the GAMP® European Steering Committee. Speaker at international seminars/conferences on several subjects related to computer systems validation and risk management. Chris has a degree in Biochemistry from Lancaster University and is a Member of the Chartered Quality Institute (CQI).
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    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 60 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    : .10 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 0.00 / € 0.00
    Non Member Price: $ 149.00 / € 122.00
    Item #: WEBANNEX11US