21 CFR Part 820 Subpart D – Document Controls

Description:

In this program we will learn about the 21 CFR 820 regulations, will also discuss the International Standards Organization (ISO), International Conference on Harmonization (ICH), Food and Drug Administration (FDA) guidance documents, as well as other standards in order to provide clarification on how 21 CFR 820 is interpreted and enforced. In the fourth part of this program (this course) we will cover document controls and their overall lifecycle.

Curriculum For This Course:

Introduction

Overview
2 mins 10 secs
ISO, ICH and the FDA
2 min 30 secs
Program organization
1 min 25 secs
Program objectives
1 min 50 secs
Definition of a medical device
2 mins 11 secs
Class I, II and III
2 mins 33 secs
Intended use
2 mins 10 secs

History of 21 CFR Part 820

21 CFR 820 Timeline
1 min 50 secs
1906 - The Jungle
1 min 45 secs
1937 - Massengil Company
2 min 10 secs
1957 - Thalidomide
1 min 58 secs
1971 - Dalcon Corporation
2 mins 33 secs
1990 - FDA device recall report
2 min 10 secs
A regulatory evolution
1 min 30 secs

Document Controls - Subpart D

Course introduction
1 min 59 secs
Learning objectives
1 min 50 secs
Document controls - Sec 820.40
2 min 55 secs
Document hierarchy
1 min 15 secs
Document approval - Sec 820.40 (a)
2 min 31 secs
Document revision
1 min 50 secs
Document revision control - Part 1
2 min 45 secs
Document revision control - Part 2
2 min 49 secs
Release Date and Effective Date
2 min 20 secs
Document change control - Sec 820.40 (b)
2 min 33 secs
Change control approves
1 min 39 secs
Change control notifications
1 min 35 secs
Document retirement
1 min 30 secs
Living documents
2 min 14 secs
Good document writing
1 min 58 secs
Clear and concise
1 min 49 secs

Conclusion

Final Exam

Certification


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Author

Don Rackham
B.S. in Molecular Biology from SJSU

Results-oriented-quality professional with over twenty years of experience in the life sciences, clinical diagnostics and the pharmaceutical industry. Extensive technical expertise in cellular analysis techniques and methods, and experience in a GMP/GLP environment.

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