Alfred Penfold, MBA, CEng, MIET, 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 joined PM Group as their GMP/Regulatory Lead and has performed GMP design reviews and quality risk assessments and has 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). Alf has been an ISPE member since 1999.