IQ, OQ, PQ in the Verification and Validation Process

Description

This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent product / equipment / process V&V requirements and execution. And now the FDA is taking an even tougher stance.

1. Why do companies need robust V&V?

2. What are the “must have” elements from the cGMPs and best practices?

3. How do you define and use IQ, OQ, PQ, or their equivalents?