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Management Forum

Understanding and Interpreting the Proposed Changes to EU (European Union) GMP (Good Manufacturing Practice) Annex 11 In-house Training

This half-day course will provide an essential update on the proposed changes to EU GMP Annex 11 and will enhance delegate's understanding of the implications on working practices, as well as including a control framework for AI and ML.

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Course overview

Learn Annex 11 for Computerised Systems — a crucial regulation for the EU and PIC/S GMP (Pharmaceutical Inspection Cooperation Scheme) countries, — to enhance compliance and system reliability in pharmaceutical operations.

In response to the evolving landscape of pharmaceutical regulations, including the proposed revisions to Annex 11 by the EU and PIC/S, this course is essential for professionals seeking to understand and adapt to forthcoming changes. With 33 areas earmarked for update and expansion, including provisions for Artificial Intelligence and Machine Learning (AI/ML) control frameworks, this program ensures participants are well-prepared for the implications on operational practices.

Understanding these changes is critical for ensuring compliance and adapting operational practices effectively. Participants will benefit from expert insights and facilitated discussions on the implications for computerized systems, validation procedures, data integrity, and risk management. 

Facilitated discussions and interactive sessions via will delve into the intricacies of these proposed amendments, providing a comprehensive exploration of Annex 11 revisions.

This course is part of ourĀ GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

  • Understand the potential impact of changes in Annex 11 on the operation and support of computerised systems
  • Know the additional requirements for agreements with suppliers
  • Be aware of the impact of the update on SaaS providers of regulated solutions
  • Secure early engagement with suppliers to ensure technical controls can meet the changes in regulations

Who should attend?

Professionals involved in the pharmaceutical manufacturing, quality assurance, regulatory affairs, and compliance should attend this course, including:

  • Process Owners (in regulated areas) and System Owners (in IT departments) responsible for the operation of GMP computerised systems
  • Computer System Validation (CSV) personnel and consultants involved with validation of regulated computerised systems
  • Quality assurance personnel involved with oversight of computerised systems
  • Suppliers who sell into regulated laboratories
  • Software as a Service (SaaS) suppliers 

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749