21 CFR Part 11 Fundamental Training

Overview

This interactive introductory course is intended to review the basic components of 21 CFR Part 11.

Course Outline

• What is 21 CFR Part 11?
• Importance of 21 CFR Part 11
• Review of Subpart A
• How Part 11 relates to other regulations
• Review of Subpart B
• Review of Subpart C
• FDA Enforcement Actions

**Class Length 4 - 6 Hours depending on customization
**Prerequisites: None

The Problem

• Are you a FDA regulated organization that needs interactive and fun Part 11 training?
  
  
• Do you need a Part 11 program that really teaches your employees the fundamentals of this important regulation?

Our Solution
To Learn...

• The basic components of 21 CFR Part 11 and how the regulation is organized and documented.
  
  
• The connection between the regulation and the systems, activities and SOPs at your firm.

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