Validation and Part 11 Compliance of Computer Systems and Data Australia 2015 is a seminar 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
- 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
Validation and Part 11 Compliance of Computer Systems and Data Australia 2015 brings together:
- 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