Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.
This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.
The course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
- Learn about the regulatory background and requirements for equipment qualification according to USP and computer system validation according to GAMP Guides
- 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 and GAMP 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 explain your company's qualification and validation strategies
- Understand how to archive raw data from hybrid systems: electronic vs. paper
- Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors
- Be able to develop inspection ready documentation during on-going routine operation
- Learn how to ensure, document and audit integrity of raw data and other records