James Hathcock
Sr Director, Regulatory and Validation Strategy
James Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Cytiva, responsible for strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He is currently an active supporting member to BioPhorum, BPSA, ASTM, ASME-BPE, PDA and ISO. He also leads the BPSA initiative on X-ray security of supply for single-use disposables, the BioPhorum Community of Practice for Extractables and leachables, and the ASME-BPE task group on single-use biocontainers; and has previously served as an expert manel member for USP <665> & <1665>. Since joining Pall in 2008, now a part of Cytiva, James has supported business continuity and security of supply challenges, led material and performance qualification of medical and biotech components, and delivered relevant technical packages supporting regulatory filings. Prior to joining Pall, James served as professor of hematology at the Mt. Sinai School of Medicine in New York City, where he directed the protein purification laboratory related to drug characterization and discovery.
DAY 2: February 28th, 2025
SESSION: Aligning expectations and risk assessment strategies for bioprocess equipment
◆ What is needed and what is not. Updated overview of standards relevant to bioprocess resk assessment and qualification.
◆ Case study examples of different single-use applications, supporting data, and risk assessment.
◆ Clearance of PERLS in lipid nanoparticle genomic medicines as well as traditional biologics manufacturing processes.
