Franz Ziel GmbH Head of GMP Compliance, PHSS Aseptic processing focus group lead
Head of GMP Compliance at Franz Ziel
James Drinkwater is the Head of GMP Compliance at Franz Ziel Germany and lead of the PHSS: Pharmaceutical and Healthcare Sciences Society Aseptic processing special interest group. Franz Ziel are the largest barrier and cleanroom technology manufacturer in Germany with international projects that include filling lines (with partners) and Gene & Cell Therapy manufacturing platforms. James engages at a consultancy level through facility and process design then oversees and supports GMP compliance through project execution. James co-leads the PHSS Annex 1 focus with the PHSS as one of the European Commission appointed EU GMP Annex 1 complementing platforms through the targeted consultation process into the final publication. The PHSS also supports training resources for PICS on implementation of Annex 1.
Thu. February 23 | 9.00am – Aseptic processing applied in Gene & Cell therapy following QRM principles
Aseptic processing principles following a Quality Risk Management (QRM) approach that includes Quality by Design (QbD).
Resolving the conflicts of EU GMP Annex 1 and GMP for ATMPs.
Applying the ATMP manufacturing platform attributes of: Flexibility/ adaptability, digitalization, modularity, scalability and intensification together with GMP compliance in a viral vector formulation and filling process including vial and bag container formats.
Characterization of protective airflow and ‘First air’ protection in bioburden control and aseptic processing steps considering how protective airflow product products, what puts protection at risk and how to manage the limitations of environmental and process monitoring (Annex1 GMP requirement).