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

  • 19-20 Jan 2015
  • Mandarin Orchard Singapore

Description

The Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data 2015 is a course 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
  • 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

The Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data 2015 is intended for:

  • 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

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

Event Categories

Business: Quality assurance, Risk Management, Security & Safety
Education: Training
Health & Medicine: Healthcare, Medical technology, Pharma

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