The European Commission is proposing the most significant updates to GMP guidelines in years. They will reshape how validation and quality teams approach compliance.
What Chapter 4 changes mean for you
How Annex 11 updates affect compliance
Understanding new Annex 22 AI rules
How to prepare your quality systems
Expert insights on regulatory timing
VP Global Operations, Korber Pharma Consulting
Stefan has more than 25 years of experience in SW development (MES) and as a consultant for the pharmaceutical industry, supporting organizations in their digital transformation. He is a speaker, moderator, instructor, and author for topics like CSV, CSA, AI/ML, Pharma 4.0â„¢, digitalization, QRM, SW development, cloud computing, and data integrity. He is a member of ISPE and chair of ISPE & VDI/VDE GAMP D-A-CH.
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