Date to be announced
Contact us for more infoTRAINING TIMES
Understand updated EU GMP Annex 1, FDA, and ICH Q9/10/12 expectations, and how to apply QRM and CCS effectively.
Learn best practices in isolators, RABS, single-use systems, APS, and monitoring for robust aseptic operations.
See how control strategies manage cross-contamination, viral containment, and lifecycle compliance in sterile products.
Analyze case studies on vial vector filling, large-scale vial lines, and robotic systems to apply proven solutions in your facility.
Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in one place - before, during, and after the course.
Receive a digital certificate (also LinkedIn-ready) that verifies your skills in strategic trial planning.
Understand the practical application of EU GMP Annex 1, ICH Q9(R1), Q10, Q12, and FDA guidance in aseptic environments, with a focus on risk-based decision making and lifecycle management.
Learn how to configure isolators, RABS, single-use and closed systems for different product types, including considerations for scalability, barrier integrity, and cleanroom zoning.
Gain hands-on understanding of how to develop Contamination Control Strategies (CCS), aseptic containment strategies (ACS), and cross-contamination controls aligned with CMC and GMP requirements.
Develop skills in environmental and process monitoring (EM/PrM), data trending, digitalisation, and metrics to evaluate contamination risks and drive continuous improvement.
Improve aseptic technique, cleanroom behavior, gowning qualification, and response to deviations. Leverage virtual reality and modern training tools to strengthen workforce readiness.
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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