Understanding and Interpreting the Proposed Changes to EU GMP Annex 11
Annex 11 for Computerised Systems is the regulation for both the European Union and counties working under PIC/S GMP (Pharmaceutical Inspection Cooperation Scheme), it was originally issued in 1992 and upgraded in 2011. A concept paper on the revision of Annex 11 contains a proposal published by EU and PIC/S to revise Annex 11 containing 33 areas for update and extension to include a control framework for Artificial Intelligence and Machine Learning (AI/ML).
This course will prepare you for the implications of the changes on working practices and will provide an opportunity to discuss the complexities with an expert in this field.
The programme will include facilitated discussions and polls using www.menti.com to explore some of the more interesting changes proposed for Annex 11.
Upcoming start dates
Suitability - Who should attend?
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
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