Alfred W. Penfold MBA, CEng, MIET

Technical Director - GMP / Regulatory Compliance, PM Group

Alf has more than 30 years of experience in the pharmaceutical and biotechnology industry, working for GSK, Catalent, and Pfizer. At Pfizer, he held multiple positions, including Engineering Lead for all manufacturing operations in the US and Canada. Alf has held similar roles in Latin America, Europe, and Asia. He was later responsible for all serialization deployments within Pfizer and has advised the FDA on serialization. Alf now works for PM Group as their Technical Director for GMP / Regulatory Compliance and has performed GMP design reviews, quality risk assessments and prepared agency review meetings, such as FDA Type C meetings, in Europe, the US, and Asia. He is an active member of the ISPE Regulatory Quality Harmonisation Committee for Europe, the Middle East, and Africa (EMEA) and is a member of the ISPE Europe Leadership Team. Alf has been an ISPE member since 1999.