Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

[Adam Fleming]

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.

• History and Overview
• Subpart A: General Provisions
• Subpart B: Electronic Records
• Subpart C: Electronic Signatures
• Scope & Application Guidance
• Questions and Answers