2 Day Virtual FDA and EU Annex 15 Process Validation Guidance & Requirements Training ...

The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...
RAPS

FDA reprimands two firms for missing validation programs, poor facility maintenance

Inadequate validation of manufacturing processes, failure to conduct microbiological testing of drugs and keeping a facility in a poor state of repair, prompted the US Food and Drug Administration ...
RAPS

FDA warns drug, device makers for CGMP violations

The US Food and Drug Administration (FDA) has issued warning letters to several drug and device manufacturers for failing to meet its current good manufacturing practices (CGMP). Among the violations, ...
Forbes

Why Validation In Life Sciences Can No Longer Be A One-Time Event

Dr. Siva Samy is the founder and CEO of ValGenesis, an inventor with 8 patents in digital and AI-based validation, and a Ph.D in Pharma. For decades, validation in life sciences has been treated as a ...