Assessing gaps and achieving compliance with Annex 1

Patrick Nieuwenhuizen

Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Fill Finish and Solid Oral Dose.

Involved with several site and laboratory expansion projects from construction design through to method transfer and operational readiness, and has provided Quality, Sterility Assurance and Microbiology oversight where relevant during these projects.

In addition to site responsibilities, involved in several corporate initiatives such as Sterility Assurance Council and the roll-out of corporate standard programs that required collaboration and communication across multiple diverse sites for the improvement and maintenance of organisational quality standards. Next to that acting as a lead auditor and have been involved with audits facing several competent authority inspections including but not limited to the HPRA, FDA, ANVISA, Chinese FDA and Canadian Health Authority inspections.

Acted as risk facilitator for Quality Risk Management programs and have gained significant experience with problem-solving and management of complex investigations.