Paul A. Gustafson

Regulatory Operations and Enforcement Branch (ROEB), Health Canada
2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor
Mr. Paul Gustafson is providing representation at the 2023 ISPE Annual Meeting & Expo as Chairperson to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). He has been a long time member of the PIC/S Executive Bureau as Chairperson of the PIC/S Sub-committee on Harmonisation of Good Manufacturing and Distribution Practices (GMDP) from January 2014 to December 2021. PIC/S is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises of 56 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).

Paul’s background includes 20 years of experience in the field of good manufacturing practices inspection with Health Canada that has been complemented with 10 years of pharmaceutical industry experience. He has gained a wealth of industry related skills through various quality related positions ranging from quality control chemist positions to vice president, quality and compliance.