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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