21 CFR Part 11 – An Introduction

Description:

The main objectives of this course are to give attendees a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). The course provides an overview of the FDA requirements with practical examples covering the implementation of those requirements. The course covers the application of these requirements to both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes.

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
Program introduction 2 min 22 secs
Module 1: The Predicate Rules
21 CFR Part 11 explained 1 min 20 secs
Electronic records 2 min 03 secs
What are the predicate rules? 1 min 20 secs
Relationship to the predicate rules 1 min 45 secs
Predicate rules and batch records 2 min 33 secs
Electronic signatures 1 min 55 secs
Handwritten signatures 2 min 10 secs
Module 2: What is Part 11
What is 21 CFR Part 11? 2 min 15 secs
Guideline 2 min 23 secs
Narrow scope and application of Part 11 2 min 48 secs
The benefits 1 min 40 secs
Module 3: E-Signatures and E-Records Explained
E-Signatures not impacted 2 min 01 secs
Module 4: Subpart A – General Provisions
Subpart A – General Provisions A-C 1 min 55 secs
Subpart A – General Provisions D-F 2 min 30 secs
Subpart A – General Provisions Conclusion 1 min 29 secs
Subpart A – General Provisions: Sec. 11.2 Implementation 2 min 03 secs
Subpart A – General Provisions: Sec. 11.3 Definitions 1 min 41 secs
Conclusion
Final Exam
Certification
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