The main market opportunities involve providing training and solutions for regulatory compliance and V&V best practices in regulated industries. This includes developing Master Validation Plans, ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

ABEC, a global leader in bioprocess engineering solutions, announced the expansion of its Process Sciences group, expanding ...

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...

Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted ...

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week. The new guidance categorizes process-validation activities into three stages. During ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide ...