Annex 1 for Medicinal Product Manufacturing
: 20 Mar 2023 - 22 Mar 2023
Sector : Pharmaceutical
Type : Training
There is a paradigm shift in GMP Regulations to meet new product requirements and 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 representing 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 live online training is provided by James Drinkwater, 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.
Register here or use the green "Request Information" button to contact the training provider for more details.