Process validation expert Walt Murray talks viewers through the new approach to process validation. Businesses are hesitant to change how they’ve been doing process validation, but Walt stresses that sticking to IQ/OQ/PQ is costly and cumbersome. Newer guidance suggests a better way to do things.
An important part of process validation is recognizing the difference between validation and verification. Walt clearly outlines what each does and in what situations they should be used. He cautions managers against assuming their processes are reliable and emphasizes that most processes are actually poorly characterized and controlled.
Risk plays an important part in newer guidance and Walt suggests using risk-based verification. He explains the risk management model and gives examples of data tools to help you understand your processes.