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 ...

Course “Validation and 21 CFR Part 11 Compliance of Computer Systems” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full ...

Dublin, Jan. 13, 2023 (GLOBE NEWSWIRE) -- The "Latest Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

Still, it would have been interesting to have a process guidance that did not use the word “validation.” It would have allowed for a clean cut away from the old “three validation runs-based” practice ...

Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.

Overview: This course provides regulatory/quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation ...

General Considerations for Process Validation - Stage 3 Continued Process Verification. A Review of EU Annex 15 and its Comparison to FDA's Process Validation Guidance.