21 CFR Part 11

21 CFR Part 11 – An Introduction

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.

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CEU Credits: 0.1
Course Code: ELM-112
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.2
Effective Date: 09/28/2021

Curriculum for this course

Overview
Learning objectives
Who should take this course
Program introduction
21 CFR Part 11 explained
Electronic records
What are the predicate rules?
Relationship to the predicate rules
Predicate rules and batch records
Electronic signatures
Handwritten signatures
What is 21 CFR Part 11?
Guideline
Narrow scope and application of Part 11
The benefits
E-Signatures not impacted
Subpart A - General Provisions A-C
Subpart A - General Provisions D-F
Subpart A - General Provisions Conclusion
Subpart A - General Provisions: Sec. 11.2 Implementation
Subpart A - General Provisions: Sec. 11.3 Definitions

Conclusion

Final Exam

Certification

Minor update: Spelling error corrected on slide titled Subpart A - General Provisions: Sec. 11.3 Definitions.
V1.2
Minor update: Section heading and associated audio fixed and course updated to modernize course design
V1.1

Author

Orlando López

E-records Integrity SME

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