Computer Systems Validation (CSV), Data Integrity, 21 CFR Part 11 Compliance and GAMP 5 2017

  • 24-25 Apr 2017
  • Mumbai, India

Description

The Computer Systems Validation (CSV), Data Integrity, 21 CFR Part 11 Compliance and GAMP 5 2017 is dedicated to proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

The Computer Systems Validation (CSV), Data Integrity, 21 CFR Part 11 Compliance and GAMP 5 2017 covers topics such as:

  • Computer Systems Validation Points
  • Role of FDA
  • Benefits of Validation
  • Why Validation?
  • 21 CFR Part 11 Compliance
  • Understanding GAMP 5
  • Data Integrity & Security
  • Annex 11
  • ALCOA
  • Where & How to know the occurrence of data integrity failures
  • URS, FS, DS, TRM, SR, IRA, FRA
  • Validation Master Plan (VMP)
  • Related Warning Letter Points
  • IQ, OQ, PQ
  • Risk Assessment
  • Computer Systems Validation Deliverables

The Computer Systems Validation (CSV), Data Integrity, 21 CFR Part 11 Compliance and GAMP 5 2017 brings together attendees from:

  • Quality Control Laboratories Companies
  • Pharmaceutical Development Companies
  • Quality Departments of Finished Product Manufacturers
  • Quality Departments of API Manufacturers
  • Biotech Companies
  • Medical Device Companies
  • Clinical Research Organisations
  • Contract Laboratories
  • Every Company that needs to comply with FDA Regulations
  • Suppliers and Service Providers of Instruments and Computer Systems

Past Events

Important

Please, check "Computer Systems Validation (CSV), Data Integrity, 21 CFR Part 11 Compliance and GAMP 5" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Innovations, Quality assurance
Education: Training
Health & Medicine: Medical device, Medical laboratories, Medical technology, Pharma
Science: Laboratories, Life Sciences & Biology
Technology: Biotechnology

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