Alfred W. Penfold
Group GMP / Regulatory SME, PM Group
Alf has more than 30 years of experience in the Pharma & Biotech industry working for GSK, Catalent and Pfizer. When joining Pfizer in 2004, he went on to perform many different roles including the Engineering Lead for all manufacturing operations in the US and Canada. He has performed similar roles in Latin America, Europe & Asia. He was later responsible for all serialisation deployments within Pfizer. He became recognised internationally as a subject matter expert in serialisation having advised the FDA. Alf joined PM Group in 2016 and as their GMP / Regulatory Lead has performed GMP Design Reviews, Quality Risk Assessments and prepared agency review meetings (e.g. FDA Type C meetings) for multiple clients in Europe, the US and Asia. Alf is an active member of the ISPE Regulatory Quality Harmonisation Committee for Europe, the Middle East and Africa (EMEA).