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
Past Events
Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data 2015 - 19-20 Jan 2015, Mandarin Orchard Singapore (47829)
Important
Please, check "Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data" official website for possible changes, before making any traveling arrangements
