Calibration and Validation of Equipment

Review a company's calibration, verification, and validation system against the critical requirements of the CGMPs and risk management. Starting with the required but often neglected Master Validation Plan, evaluating ISO 14971 and ICH Q9 risk analysis and documentation requirements in hazard analysis and product risk management, and a solid calibration program allows the development of meaningful product quality-specific equipment validations. Consider Human Factors / Use Engineering elements where required. A variety of V&V protocols will be presented and discussed, including how to employ equipment test cases in IQs, OQs, and PQs, or their equivalents. The QSR / QMSR / ISO 13485 and 21 CFR Part 11 and cybersecurity are also discussed and where they are to be incorporated in validation.