Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.
Duration:
90 Minutes
Product Id:
502899
Access:
6 months
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Overview:
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.
Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in project management, and avoidance of non-compliance penalties.
Areas Covered in the Session:
- History and Overview
- Subpart A: General Provisions
- Subpart B: Electronic Records
- Subpart C: Electronic Signatures
- Scope & Application Guidance
- Questions and Answers
Who Will Benefit:
- Project/Strategic Management
- IT staff
- Operations staff
- Quality Assurance staff