Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ ...
Dublin, Aug. 15, 2023 (GLOBE NEWSWIRE) -- The "Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Course" training has been added to ...
The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...
European Medicines Agency (EMA) which has been following the US FDA guidelines on Process validation so long, has now revised the process validation norms. The revision incorporates the principles of ...
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider ...
DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
(MENAFN- GlobeNewsWire - Nasdaq) This training session presents opportunities in enhancing compliance and efficiency in drug manufacturing by deepening understanding of FDA and EU guidelines, ...
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