Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts 2015 is a webinar that covers topics such as:
- Computerized System Validation Master Plan
- Introduction, Historical Perspective, and Definitions
- Developer Assessment
- Validation Plan
- Validation Testing
- Requirements, Design, and Configuration Specifications
- Validation Summary Report
- Procedures/Archival/Traceability
- System Decommissioning/Retirement
- Commissioning Memo
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts 2015 is intended for:
- Quality assurance staff
- Project/strategic management
- Operations staff
- IT staff
- Staff members involved with project planning, computerized system validation, system use, validation testing, regulatory compliance of computerized systems and system support