GAMP CoP UK Forum

Join us at the next GAMP CoP UK Forum, 19-Sep-2023 at Imperial College London. Topics will include Agile Software Development, Application Lifecycle Management, Supplier Assessment, Validation of AI, and Digital Solutions for Lab Operations. Register to attend via the ISPE website

GAMP CoP UK Forum

The next GAMP CoP UK Forum will be held on 25-Apr-2023. Topics will include Computer Software Assurance (CSA), Blockchain Validation, Lab Equipment Qualification, Cell & Gene Therapy, and applying ISPE GAMP 5 2nd Edition. Register to attend via the ISPE website.

EU GMP Annex 11 Concept Paper

The European Medicines Agency (EMA) has published a concept paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice (GMP) for medicinal products - Computer Systems. The proposed guidelines will replace Eudralex Volume 4: Annex 11 Computerised Systems.