21 CFR Part 820 Subpart C – Design 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 third part of this program (this course) we will cover design controls which are the foundation of product quality.

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
Design Controls – Subpart C
Course introduction 2 min 09 secs
Introduction to design controls – Sec 820.30 (a) 2 min 10 secs
Lifecycle approach 1 min 58 secs
Marketing requirements 1 min 38 secs
Feasibility 2 min 33 secs
Documentation 2 min 10 secs
Design and development planning – Sec 820.30 (b) 1 min 42 secs
Goals and objectives 2 min 44 secs
Task breakdown 1 min 44 secs
Over optimistic schedule 2 min 25 secs
Design input – Sec 820.30 (c) 1 min 48 secs
User needs 2 min 02 secs
Design input requirements 2 min 52 secs
Unambiguous requirements 1 min 49 secs
Complex products 1 min 58 secs
Design output – Sec 820.30 (d) 2 min 14 secs
Design review – Sec 820.30 (e) 1 min 30 secs
Collection of reviewers 1 min 35 secs
Systematic process 1 min 39 secs
Design verification – Sec 820.30 (f) 2 min 33 secs
Verification studies 2 min 20 secs
Design validation – Sec 820.30 (g) 1 min 43 secs
Validation plan 2 min 49 secs
Clinical evaluations 2 min 45 secs
Not a single document 1 min 50 secs
Design transfer – Sec 820.30 (h) 2 min 31 secs
Design changes – Sec 820.30 (i) 1 min 43 secs
Change control process 2 min 10 secs
Change levels 1 min 15 secs
Design history file – Sec 820.30 (i) 2 min 55 secs
Device master record 1 min 50 secs
Design control conclusions 1 min 59 secs
Conclusion
Final Exam
Certification
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