FDA 21 CFR Part 11 Electronic Signatures-Requirements

This ON DEMAND 1-hour e-course teaches a brief overview of the key concepts and major requirements of the FDA Part 11 Electronic Records and Signatures and includes certified training Certificate of Competence. 0.1 CEUs.

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Course curriculum

  1. 1
    • 1 - How to use this course

  2. 2
    • Electronic Signatures_Lesson-02

    • Electronic Signatures_Lesson-02_QUIZ

  3. 3
    • Electronic Signatures_Lesson-03

    • Electronic Signatures_Lesson-03_QUIZ

  4. 4
    • Electronic Signatures_Lesson-04

    • Electronic Signatures_Lesson-04

  5. 5
    • Congratulations

Learning Objectives

Upon completion of this training, students will be able to:

  • Interpret the clauses and recognize the application of Part 11

  • Understand the roles and responsibilities to support compliance to the standard

  • Understand requirements to inform FDA of intent to use electronic signatures

  • Be prepared for Part 11 inspections

Course Categories

Lead Auditor | Internal Auditor | Requirements | Overview

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FDA 21 CFR Part 11 Electronic Signatures-Requirements