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
Trainers
EU GMP & PIC/S Annex 1 Challenges & Solutions to Compliance
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
