21 CFR Part 11 – 2003 Guidance

Description:

This course covers the August 2003, US FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application, establishing the enforcement discretion to the regulation, 21 CFR Part 11. In this course we will focus on the Guidance for Industry and discuss the most important elements of this part of the regulations.

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
21 CFR Part 11 – 2003 Guidance
Issues with Part 11 1 min 20 secs
Application and Enforcement Discretion 2 min 03 secs
Application – Part 1 1 min 20 secs
Application – Part 2 1 min 45 secs
What Specific Electronic Records are in Scope of Part 11? 2 min 33 secs
Out of Scope – Records and Signatures 1 min 55 secs
Enforcement Discretion – Overview 2 min 23 secs
Enforcement Discretion – Validation 2 min 10 secs
Enforcement Discretion – Audit Trail 1 min 40 secs
Enforcement Discretion – Legacy Systems 1 min 40 secs
Enforcement Discretion – Copies of Records 2 min 01 secs
Enforcement Discretion – Record Retention 1 min 55 secs
Final Guidance Summary 2 min 30 secs
21 CFR Part 11 Resources and Guidance from the FDA 1 min 29 secs
Conclusion
Final Exam
Certification
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