DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Analytical Instrument Qualification and System Validation" conference to their offering.
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.
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.
- 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
For more information about this conference visit http://www.researchandmarkets.com/research/x2mmhp/analytical