Validation and Part 11 Compliance of Computer Systems and Data 2016

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
• And Implement the new UK MHRA GMP Data Integrity Guideline
• Explain the difference between equipment calibration, qualification and system validation
• Allocate equipment and systems to USP 1058 and GAMP categories and to design and execute qualification/validation protocols accordingly
• Which equipment/systems need to be qualified or validated
• Explain your company`s qualification and validation strategies
• The logic and principles of instrument qualification and system validation from planning to reporting
• Define and demonstrate Part 11 compliance functionality to auditors and inspectors
• How to archive raw data from hybrid systems: electronic vs. paper
• How to avoid and/or respond to FDA inspectional observations and warning letters
• Develop inspection ready documentation during on-going routine operation

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

From:

• Quality control laboratories of API manufacturers
• Pharmaceutical development and Quality control laboratories
• Clinical Research Organization
• Contract laboratories
• Suppliers of analytical instruments and laboratory computer systems