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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