Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...

製薬工場の製造オペレータの仕事は、日々たくさんあります。そのなかでも花形の業務は、バリデーション。転職市場でも、バリデーション業務に携わっていると重宝されます。 わたしは新卒で製造オペレータを担当し、1年目からプロセスバリデーション ...

すべての製薬製造プロセスの品質を管理するPQMS Quascentaは、PQMSソフトウェアスイートを通じて、プロセス（Process）の品質（Quality）を管理（Management）する包括的なスイート（Suite）エコシステムを推進しています。このような製薬製造の品質エコシステムの ...

The author describes why statistical significance would impose an unreasonable burden on manufacturers. Validation has been practiced within the global healthcare industry since the early 1970s. While ...

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

Dublin, Feb. 25, 2026 (GLOBE NEWSWIRE) -- The "Process Validation for Medical Devices Training Course (June 4th - June 5th, 2026)" training has been added to ResearchAndMarkets.com's offering. This ...