IQ, OQ, PQ in the Verification and Validation Process

Description

This course will guide you on how to develop or improve upon DQ, IQ,  OQ and PQs and the  Master Verification and Validation Plan / System that meets risk / U.S. FDA cGMP, ICH Q-series, and ISO 13485 requirements; based on product use hazard analysis per ISO 14971:2019 and ICH Q9.

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.  One major failing is lack of sufficient or targeted risk-based company-wide V&V planning, with major problems in a validation's DQ, IQ, OQ, and PQs.  A Master Validation Plan is not specifically mentioned in the cGMP's.  However, one is expected by the US FDA, under the "c" in cGMP. And, with increasing technology, both industry and regulatory agencies expectations have increased.  Recent field problems indicate that V&V activities are not planned or carried out as completely as expected, don't fully utilize the power of current…