2020 - Analytical Instrument Qualification and System Validation

Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5
Be able to explain the difference between equipment calibration, qualification and system validation
Learn which equipment/systems need to be qualified or validated
Be able to allocate equipment and systems to USP <1058> and GAMP 5 categories and to design and execute qualification/validation protocols accordingly
Understand the logic and principles of instrument qualification and system validation from planning to reporting
Be able to develop a qualification and validation strategy
Understand how to archive raw data from hybrid systems: electronic vs. paper
Be able to define and demonstrate regulatory compliance to auditors and inspectors
Be able to develop inspection-ready documentation
Learn how to ensure, document and audit the integrity of GMP records