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2024 ISPE Singapore Affiliate Conference & Exhibition
28-30 August 2024 | Suntec Singapore & Online
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Paul Gustafson

GMP Inspection Supervisor & Chairperson, PIC/S - Health Canada

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Professional Bio

Mr. Gustafson is currently the PIC/S Chairperson.  He has been a member of the PIC/S Executive Bureau since January 1, 2014 with a role as as Chairperson of the PIC/S Sub-committee on Harmonisation of Good Manufacturing and Distribution Practices (GMDP) from 2014-2021. The Pharmaceutical Inspection Co-operation Scheme known as 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 54 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).

Paul is also a Regional Regulatory Compliance and Enforcement Supervisor within the Regulatory Operations and Enforcement Branch of Health Canada. The Health Product Inspection and Licensing Division within this branch supports the assessment of GMP compliance of establishments engaged in various activities relating to veterinary drugs, human drugs, and active pharmaceutical ingredients.

Paul’s background includes 19 years of experience within 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.