21 CFR Part 11 – Electronic Signatures

Description:

The main objectives of this course are to give learners a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). This online course provides an overview of the FDA requirements with practical examples covering the implementation of those requirements.

Curriculum for this course:
Introduction
Overview 2 mins 10 secs
Learning Objectives 2 mins 15 secs
Who should take this course? 1 min 40 secs
Course Modules 2 min 22 secs
Module 1: Subpart C – Electronic Signatures
Electronic Signature Requirements 1 min 20 secs
Electronic Signatures General Requirements – 21 CFR Part 11.100 2 min 03 secs
21 CFR Part 11.100(a) – Unique 1 min 20 secs
21 CFR Part 11.100(b) – Authenticates 1 min 45 secs
21 CFR Part 11.100(c)(1)(2) – Legally Binding 2 min 33 secs
Electronic Signatures Components and Controls – 21 CFR Part 11.200 1 min 55 secs
21 CFR Part 11.200(a)(1)(i)(ii) – Electronic Signatures 2 min 23 secs
21 CFR Part 11.200(a)(2)(3)(b) – Genuine Owners 2 min 10 secs
Electronic Controls for Identification Codes/Passwords – 21 CFR Part 11.300 1 min 40 secs
21 CFR Part 11.300(a) – Uniqueness 1 min 40 secs
21 CFR Part 11.300(b) – Passwords Changed Periodically 2 min 01 secs
21 CFR Part 11.300(c) – Loss Management Procedures 1 min 55 secs
21 CFR Part 11.300(d) – Unauthorized Attempts Detected 2 min 30 secs
21 CFR Part 11.300(e) – Periodic Testing 1 min 29 secs
Electronic Signatures Summarized 1 min 41 secs
Conclusion
Final Exam
Certification
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