Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data 2015

Key Topics

• 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

Who should Attend

• 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