Date to be announced
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current and learn about new regulation changes e.g., EU GMP Annex 1 and the key points that impact biological product Fill & Finish and possible compliance gaps.
about the full expectations of applying QRM and what a CCS is expected to cover in the process of defining the approach to sterile product manufacturing including organisational, technical and procedural control measures.
the expectation of collective effectiveness with EM & PM with trend metrics that drive continuous improvement through the product life cycle.
about the key challenges related to biological product filling including sensitivity to disinfection oxidising agents (VHP) and how to manage/control impact on products to meet regulatory and product quality requirements.
about the technologies that are integrated into filling process platforms to meet the various critical quality attributes of biological products.
about best practices in biological product aseptic manufacturing and regulatory observations in non-compliance.
about the trends and future of biological product Fill & Finish.
Designed for professionals who want to enhance their expertise and advance their careers
Franz Ziel GmbH, Head of GMP Compliance
James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups. James is also the leader of the PHSS Aseptic processing and Biocontamination special interest group that develops GMP guidance documents that are subjected to regulatory review before publication. James is also a member of ISPE and PQG (Pharmaceutical Quality Group UK). Current projects relative to this training span biological product filling lines, ATMP (Advanced Therapeutic Medicinal Products) combined formulation and filling platforms and associated sterility testing.
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