Alfred Penfold

PM Group
Technical Director - GMP / Regulatory Compliance
Alfred Penfold has more than 35 years of experience in the pharmaceutical and biotechnology industry working for GSK, Catalent, Pfizer and PM Group. 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, for clients in Europe, the US, and Asia. He is a member of the ISPE Regulatory Quality Harmonisation Committee’s EMEA Regional Focus Group’s steering committee, a member of the ISPE Europe Leadership Team and an elected member of the PHSS Management Committee. Alf has been an ISPE member since 1999.

Related Articles

ATMP Regulations - Comparison of EudraLex Part IV with PIC/S Annex 2A
iSpeak Blog
ATMP Regulations - Comparison of EudraLex Part IV with PIC/S Annex 2A

ATMPs are based on genes, cells or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as ‘Personalised Medicine’. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived...