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, ...

Here’s the situation: Your development team is busy creating a Minimum Viable Product (MVP). You have people off in all directions trying to secure some funding. But do you have a Market Validation ...

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 ...

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, ...

Why Should You Attend: Verification and validation requirements have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have ...

This article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing ...

Even with technology changing faster than validation procedures can be rewritten, it still is possible to perform thorough product testing. With the ever-changing complexity of automotive electronics ...

A business plan serves as a roadmap towards startup goals and objectives. Some of the biggest assumptions of a completed business plan is the viability and validity of the solution and the path to ...

Why Should You Attend: Verification and validation requirements have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have ...