Upcomming Course
Jun 27, 2020 - Jun 28, 2020
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Course Description

Who Should Attend

Target Areas

Build an in-depth knowledge of validation through to latest GAMP® 5 guidance, and specific FDA regulatory requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures from planning to reporting.

  • Understand the FDA and EU Regulatory requirements
  • Best practices for Instrument Qualification & Computer System Validation
  • Overview of GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
  • The GAMP system lifecycle and specifications
  • Validation & Control of Excel spreadsheets
  • Quality Risk Management for computerized systems
  • Revised EU Annex 11 Computerized Systems, including the official GAMP interpretation of key aspects
  • FDA 21 CFR Part 11 Update, including the current FDA interpretation
  • A Risk-based approach to Electronic Records and Signatures to meet both FDA and EU expectations
  • Quality Assurance and Quality control Specialist
  • Validation Specialist
  • IT/IS managers and system administrators
  • QA managers and personnel
  • Laboratory Managers and Supervisors
  • Analysts
  • Validation Specialists
  • Software Developers
  • Regulatory Affairs
  • Training Departments
  • Documentation Departments
  • Consultants


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Section 1demo
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Section 2demo2
Final Quiz