Annex 1 vs FDA: Where Contamination Control Strategies Fail at Inspection

Annex 1 and the US FDA both expect a robust Contamination Control Strategy, but they don't always look for the same things, and that gap is where many sites get caught out at inspection.

In this opening session of the Pharmig India webinar series, presented by Pharmig (UK) with Pharma Now, Patrick Nieuwenhuizen of Paradigm Quality Consultancy and Pharmig committee member draws on more than 30 years of industry experience to walk through where CCS documents and practices most often fall short.

He will cover the differences in expectations between EU GMP Annex 1 and FDA guidance, and the practical fixes that hold up under scrutiny. The 60-minute conversation includes a short framing talk, a moderated discussion and live audience Q&A. It is built for microbiology, QA/QC and sterility assurance professionals.