ANNEX 1

    Annex 1 for Medicinal Product Manufacturing

    20 – 22 March 2023, live online training

    Summary

    This 3-day online training will cover EU GMP Annex 1 Good Manufacturing Practice for Medicinal products for human and veterinary use; EU Guidelines on Good Manufacturing practice specific to Advanced Therapy Medicinal Products (ATMPs) and Quality Risk Management: QRM applied as a fundamental principle in medicinal product manufacturing applied over the Product Life cycle.

    Background

    There is a paradigm shift in GMP Regulations to meet new product requirements, support new technologies that improve assurance of sterility with a collective approach of Risk based (ICHQ9-QRM), Holistic (Collective effectiveness of control measures) and Proactive (Informed response to deviations). Annex 1 has been rewritten to support this new paradigm that represents the most significant change in GMP regulations in many years.

    The publication of Annex 1 with compliance required by 25 August 2023 is challenging all to understand requirements, develop strategies to comply and potentially make changes to achieve full GMP compliance.

    This training is provided by a Trainer who was the Co-lead (together with an Ex-MHRA GMP Inspector) of the PHSS Annex commenting platform in the Targeted consultation process that led to the most significant changes to Annex 1 on the route to publication. The PHSS were one of the appointed Annex 1 Commenting platforms, appointed by the European Commission, to co-ordinate comments from Stakeholders. The trainer also represented the PHSS in the Commenting Group association that included the (12) organisations appointed by the EC. This group harmonised comments and presented case studies to the Inspectors Working Group (IWG) on possible justifications for extended Annex 1 implementation.

    In addition the Trainer co-leads the PHSS CCS preparation Guidance initiative and can share case studies and experiences of implementing CCS preparation at a Single ATMP site and Group of International Pharmaceutical Sites (UK, Croatia, Israel) taking a harmonised approach to CCS.

    With Annex 1 published the focus is now on understanding clarity of requirements and implementation.

    There is much to share and learn in this training and participation is encouraged for all that Annex 1 impacts.

    Who should attend?

    Through the Gap analysis to consider compliance requirements to meet Annex 1 revision and through the CCS (Contamination Control Strategy) preparation all involved would benefit from this training, including from: QA involved in Annex 1 compliance and those facing GMP inspectors and auditors; QC (QC Microbiology and Chemistry); Qualified Persons (QPs); Production operations: All levels, supervisors and lead operatives; Materials, Science and Technology groups; Maintenance leads that support production operations; Engineering and Qualification teams; GMP consultants; Process equipment, Barrier Technology designers and manufacturers; Contract Manufacturing organisations (CMOs) and Contract Development and Manufacturing organisations (CDMOs); GMP trainers

    Key takeaways

    • Appreciate the significant international relevance of the joint publications of EU GMP Annex 1 and PICS Annex 1
    • Get clarity on new and revised Annex 1 requirements and regulatory intent
    • Understand the intent and impact of ICH Q9 QRM revision and introduction of ICHQ12 on Product life cycle
    • Understand what are the Pharma industry and ATMP community challenges for compliance to Annex 1
    • Get examples of justifications for extend implementation times for Annex 1 compliance

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 30 days
    • Training in digital format
    • Digital and LinkedIn certificates

    Trainers

    James L. Drinkwater trainer
    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

    Annex 1 for Medicinal Product Manufacturing

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 056 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate
    .

    Price per delegate including:

    Online participation

    Online workbook & materials

    Certificate

    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543

    Training Details
    • Start Date
      20. March 2023
      09:00 AM Vienna time
      08:00 AM London time
      04:00 AM New York time
      01:00 AM Los Angeles time
    • End Date
      22. March 2023
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