Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK guidelines, and GAMP standards grants ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...

This training is designed for those with responsibility for the design, execution, or validation of cleaning processes which may include operations managers and personnel, validation specialists, ...

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 ...

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 ...

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 ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

This training is designed for those with responsibility for the design, execution, or validation of cleaning processes which may include operations managers and personnel, validation specialists, ...