Annex 1 Compliance: Challenges & Solutions (EU GMP & PIC/S)

    10-12 October 2023, live online training

    Course Description

    Training course on achieving current GMP Compliance to EU GMP & PIC/S Annex 1 that is effective from 25 August 2023. Alongside Annex 1 revision the ICHQ9(R1) QRM has been revised and ICHQ12 on Product Life Cycles introduced so the impact of ICH Guidance’s on GMP compliance will be included.

    Together revised regulations, ICH guidance’s and associated principles present a paradigm shift in current GMP towards a Risk based; QRM, Holistic; Collective and Effective Control Measures and Proactive; trending and more advanced monitoring for signals in the change of the Established Conditions (ECs) control state required by Annex 1 in manufacture of sterile medicinal and therapeutic products plus bioburden control in processing biological intermediates and non-sterile products.

    Annex 1 presents challenges of new regulatory requirements, revised regulatory requirements (more to do) and in some requirements clauses lack clarity where understanding the regulatory intent is key to interpretation.

    The training course focuses on the challenges presented by Annex 1 and considers solutions to meet current GMP compliance that are being applied or considered to mee the effective Annex 1.

    Who should attend?

    Annex 1 has such a wide scope of interest and application so many will benefit from this course, including;

    QA and QC personnel involved in sterile medicinal product manufacture; Those involved in ATMP, Advanced Therapeutic Medicinal Product processing as the GMP for ATMPs is considered as complimentary to Annex 1; Those involved in CCS: Contamination Control Strategy preparation; Those involved in Risk assessments for Contamination control, monitoring, Product sterilisation by filtration including PUPSIT; Production and operations personnel involved in manufacture of sterile medicinal products; Qualified persons responsible for product release; Materials Science and Technology: MSAT personnel; Facility and process equipment designers/ manufacturers for GMP applications; Monitoring technology companies and software developers; Researchers that need to consider the commercialisation of new products to meet GMP compliance; GMP consultants

    Key takeaways

    • Understand the international relevance of the revised Annex 1 and the impact it is having on stakeholders
    • Understand the significance of ICHQ9(R1) revision that becomes effective around the same time as Annex 1
    • Bench mark what the challenges are that stakeholders are having to deal with considering requirements and clarity
    • Evaluate solutions presented to meet the revised Annex 1 Compliance
    • With Contamination Control Strategies prepared or incomplete bench mark against published CCS guidance to identify gaps or present a way forward to compliance
    • Understand what the expectations are for legacy facilities, equipment following Annex 1 becoming effective 25 August 2023
    • There is encouragement to new technologies and more real time monitoring systems in Annex 1, understand the status of implementation and remaining challenges for adoption

    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 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    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 Compliance: Challenges & Solutions (EU GMP & PIC/S) 

    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. 1 997 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


    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
    +421 222 200 543

    Training Details
    • Start Date
      10. October 2023
      09:00 AM Vienna time
      08:00 AM London time
      03:00 AM New York time
      12:00 AM Los Angeles time
    • End Date
      12. October 2023
    What participants said about Symmetric courses

    "I was happily pleased with the enormous experience of the trainer, i enjoyed it a lot and learned a lot."
    Senior Development Pharmacist, Orion Corporation

    "Keep up the excellent standard of training courses!"
    FDF Industrialisation Manager, Medichem Manufacturing

    "I have received a lot of knowledge that will be of big use for my profession."
    Quality manager, Vironova AB

    "Thank you for a very informative training course. The timing of start/break/finish was perfect."
    Clinical Project Manager, Regen Lab

    "Would highly recommend this course, great practical insights throughout helped to make it all very real, many thanks."
    Head of API and Contract Manufacturing, Zentiva Group

    "Very informative and memorable training course for me."
    Quality Vice President, Darou Pakhsh

    "The trainer was very knowledgeable about the topics and was able to answer all questions."
    Drug Product Subject Matter Expert, Pfizer

    "Excellent speaker with great hands-on experience and many pragmatic examples."
    Quality Director, Boston Scientific

    "James Drinkwater has an exceptional experience setting up new facilities and therefore a fantastic perspective on how to best setup a facility meeting the best design and quality standards. It was great to listen to his perspective."
    Group Leader CMC, AC Immune

    Training Material Preview