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
Past Events
Validation and Part 11 Compliance of Computer Systems and Data Australia 2015 - 10-11 Dec 2015, Hilton Sydney, Australia (55592)
Validation and Part 11 Compliance of Computer Systems and Data Australia 2026
Important
Please, check "Validation and Part 11 Compliance of Computer Systems and Data Australia" official website for possible changes, before making any traveling arrangements
