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, ...

Training evaluation is the process that examines the effectiveness of your educational and training programs. Validation is the process that certifies the training employees are receiving meets ...

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 ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

The author describes why statistical significance would impose an unreasonable burden on manufacturers. Validation has been practiced within the global healthcare industry since the early 1970s. While ...