Mena FN

2-Day Online Process Validation Guidance Requirements Course: July 25-26, 2024 (FDA And EU Annex 15: Qualifications And Validation)

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, May 24, 2024 (GLOBE NEWSWIRE) -- The "Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Course" training has ...
Becker's Hospital Review

FDA proposes new endpoints for multiple myeloma drug trials

The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft ...
JD Supra

FDA Finalizes Guidance for Using Real-World EHRs and Medical Claims Data to Support Regulatory Decisions for Drug Products

The guidance outlines key issues for determining the reliability and relevance of the data and that should be addressed in the study protocol, including: the appropriateness and potential limitations ...

WEBINAR: FDA's 21 CFR Part 11 Add-on Inspections: Address Software That is Supporting the Company's Quality System and CGMP Documentation

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...
Yahoo Finance

IQ, OQ, PQ in the Verification and Validation Process Training Course: Master V&V Planning Aligned With FDA cGMP, ICH Q-Series, ISO 13485, and ISO 14971 Risk Management (ONLINE ...

Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "IQ, OQ, PQ in the Verification and Validation Process (Jan 28, 2026)" training has been added to ResearchAndMarkets.com's offering. This course will ...
News Medical

The Role of Process Validation in Ensuring Consistent Drug Quality

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 ...