Business Wire

Process Validation Guidance Requirements: FDA and EU Annex 15: Qualifications and Validation - ResearchAndMarkets.com

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 ...
MD&M East

The Ins and Outs of Laser Process Validation

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...
EDN

Steering a battery manufacturer’s application through the U.S. FDA validation process

A recent change in outlook at the U.S. Food and Drug Administration (FDA) — the government body that regulates the use of devices and substances in medical care — has escalated the already rigorous ...
PharmTech

CAR-T and Process Validation (PDA/FDA Joint Regulatory Conference 2023)

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T ...