Assessing Gaps And Achieving Compliance With Annex 1

In this podcast episode focused on Assessing gaps and achieving compliance with Annex 1, Patrick Nieuwenhuizen shares his insights and expertise gleaned from extensive experience in pharmaceutical regulation and compliance.

Nieuwenhuizen is a seasoned quality professional boasting over 25 years of experience in the Pharmaceutical Industry, specializing in Microbiology & Sterile Manufacturing. He has contributed my expertise to various global Pharmaceutical and Biotechnology companies, spanning Biologics, Sterile Fill Finish, and Solid Oral Dose platforms, with involvement extending to numerous site and laboratory expansion projects. Throughout these endeavors, Nieuwenhuizen has provided oversight in Quality, Sterility Assurance, and Microbiology to ensure adherence to relevant standards.

Beyond site responsibilities, he has actively participated in corporate initiatives such as the Sterility Assurance Council and the implementation of standardized programs across diverse sites. This involved fostering collaboration and communication to enhance and sustain organizational quality standards. Additionally, Nieuwenhuizen has served as a lead auditor, participating in audits and facing regulatory inspections from authorities like HPRA, FDA, ANVISA, Chinese FDA, and Canadian Health Authority.

Furthermore, he's played a pivotal role as a risk facilitator for Quality Risk Management programs, honing his skills in problem-solving and managing intricate investigations.