Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Master Validation Plan - The Unwritten Requirements" training has been added to ResearchAndMarkets.com's offering. FDA Warning Letters and recent ...

You know you need a validation master plan, but what should it include and what separates a strong validation master plan from an ineffective one? Marie Thibault We asked Ken Link, director of quality ...

Every medical device company (OEM) must meet certain standards for validation of its transfer plans, facilities, clean rooms and processes. These standards apply for OEM’s and suppliers to OEM’s. Many ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...