HPRA WEBINAR- 3rd October 2024
This webinar will be a continuation of the Quality Defects & Recalls webinar that was run by BioPharmaChem Skillnet in conjunction with the HPRA in June 2023. It will address current topics in relation to quality defects and recalls, including real life examples and tips for investigating defects and managing recalls. Case studies will be presented showing the application of quality risk management principles to quality defects and other issues. The presenters will be from the HPRA’s Market Compliance Section.
During the webinar we may also discuss potential changes being considered for the EU GMP Guide, to incorporate into the GMP’s key concepts from the new guidance in ICH Q9(R1). (ICH Q9 was revised in 2023 and it provided new guidance in a number of areas)
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