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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