The Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data 2015 is a course that covers topics such as:
- How to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
- The regulatory background and requirements for equipment qualification according to USP 1058, computer system validation according to GAMP Guides
- Which equipment/systems need to be qualified or validated
- The difference between equipment calibration, qualification and system validation
- The logic and principles of instrument qualification and system validation from planning to reporting
- Equipment and systems to USP 1058 and GAMP categories
- How to archive raw data from hybrid systems: electronic vs. paper
- Company`s qualification and validation strategies
- Inspection ready documentation during on-going routine operation
- Part 11 compliance functionality to auditors and inspectors
- How to avoid and/or respond to FDA inspectional observations and warning letters
The Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data 2015 is intended for:
- QA managers and personnel
- IT/IS managers and system administrators
- Analysts
- Laboratory managers and supervisors
- Software developers
- Validation specialists
- Training departments
- Regulatory affairs
- Consultants
- Documentation departments
- Pharmaceutical development and Quality control laboratories
- Companies and departments
- Contract laboratories
- Quality control laboratories of API manufacturers
- Suppliers of analytical instruments and laboratory computer systems
- Clinical Research Organisation