How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future? General guidelines regarding ...

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ResearchAndMarkets.com's offering.

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

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 ...

My first high school foreign language class was an eye-opening experience. I remember knowing a few words of the language from my middle school years but not at all expecting what I was to encounter: ...

Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards ...

This course provides candidates with practical tools for validation including, qualification, process validation and analytical method validation. Incorporating facility/equipment qualification, ...

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 ...

In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means. As the biotech industry evolves, ...

DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ResearchAndMarkets.com's offering. The Process ...