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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
Lecture 1wqwq
Lecture 2wwwwww
Section 2demo2
Final Quiz