Validation and Part 11 Compliance of Computer Systems and Data Australia 2015

  • 10-11 Dec 2015
  • Hilton Sydney, Australia

Description

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

Past Events

Important

Please, check "Validation and Part 11 Compliance of Computer Systems and Data Australia" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Pharma

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