James L. Drinkwater
James Drinkwater is the Head of Aseptic processing technologies and GMP compliance at F Ziel Germany supporting international Pharmaceutical manufacturing/ Filling projects from a UK base. In addition, James has an elected voluntary role as Chairman of the not for profit society: PHSS – Pharmaceutical and Healthcare sciences society that provides education in Good Manufacturing Practice (GMP) and leads the PHSS Aseptic processing and Bio-contamination special interest group.
James is a qualified Pharmaceutical process engineer with additional education in Pharmaceutical microbiology and an international conference speaker actively supporting the PHSS, PDA, ISPE, and UK PQG (Pharmaceutical Quality Group) events. James is a lecturer on QP training courses and a qualified trainer (SME) on Barrier Separation Technology: RABS and Isolators with integrated hydrogen peroxide vapor bio-decontamination systems used in Aseptic processing.
James current specialization at F Ziel GmbH is in the area Aseptic processing for sterile product manufacturing including biological products and ATMPs, filling and sterility testing, working actively on projects providing support in process design, control strategies, risk-based process control and monitoring for solutions in contamination and cross-contamination control together with GMP compliance.
James heads up a Microbiological and analytical chemistry laboratory in F Ziel Germany working on biological indicators pre-use qualifications and biocompatibility studies including Biological product compatibility with oxidizing agent residuals e.g.H202.