FDA 21 CFR Part 11 Electronic Signatures-Requirements [Engli

FDA 21 CFR Part 11 Electronic Signatures-Requirements

This 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. Language: English.

Enroll Now $295

Course Curriculum

1. 1 - How to use this course
1. Electronic Signatures_Lesson-02
2. Electronic Signatures_Lesson-02_QUIZ
1. Electronic Signatures_Lesson-03
2. Electronic Signatures_Lesson-03_QUIZ
1. Electronic Signatures_Lesson-04
2. Electronic Signatures_Lesson-04_QUIZ
1. Video-Congratulations-Next Steps

FDA 21 CFR Part 11 Electronic Signatures-Requirements

$295.00
On Demand / Student-Paced
1 hours / 0.1 CEUs
English
Certified Training

Learning Objectives

Understand the clauses and recognize the application of Part 11
Know 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

Certified Training Recognized Globally

Digitally verifiable certificates issued by a trusted global training provider.

Our certificates are secure, digitally issued, and verifiable online by any third-party, registrar, or certification body. You can easily add your credential to your LinkedIn or other social media profile.

Enroll Now $295

FDA 21 CFR Part 11 Electronic Signatures-Requirements

Course Curriculum

Welcome to the course!

Introduction | FDA Inspection questions | Subpart A – General Provisions

Subpart B – Electronic Records

Subpart C – Electronic Signatures | Summary Checklist

Next steps

FDA 21 CFR Part 11 Electronic Signatures-Requirements

Learning Objectives

Certified Training Recognized Globally