21 CFR Part 820 Subpart I – Nonconforming Products

Description:

In this course you will learn about nonconforming product and product that fails to meet a requirement, need, expectation or obligation and how each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.

Curriculum for this course:
Introduction
Overview 2 mins 10 secs
ISO, ICH and the FDA 1 min 30 secs
Program organization 1 min 20 secs
Program objectives 1 min 25 secs
Definition of a medical device 1 min 50 secs
Class I, II and III 2 mins 11 secs
Intended use 1 mins 33 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
Nonconforming Products – Subpart I
Course introduction 1 min 10 secs
Learning objectives 56 secs
Nonconforming products – Sec 820.90 1 min 31 secs
Extend to other systems 1 min 55 secs
Out of specification (OOS) 1 min 25 secs
Management of nonconformance’s 1 min 48 secs
The NCR process 1 min 30 secs
Disposition decision 1 min 39 secs
The material review board 1 min 50 secs
The QA manager 1 min 52 secs
Deviations 1 min 22 secs
Deviation example 1 min 40 secs
Planned deviations 1 min 15 secs
Deviation systems 1 min 55 secs
Conclusion
Final Exam
Certification
Author:

Start Learning Today!

We’ve got pricing plans to suit everyone

View Our Pricing Plans