21 CFR Part 820 Subpart E – Purchasing Controls

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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 fifth part of this program (this course) we will cover all of the key aspects of purchasing controls required within a regulated medical device environment.

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

Purchasing Controls – Subpart E

Course introduction	2 min 20 secs
Learning objectives	1 min 50 secs
Purchasing controls – Sec 820.40	2 min 14 secs
Purchasing control example	1 min 39 secs
Returned devices	2 min 55 secs
Supplier evaluation – Sec 820.50	2 min 14 secs
Supplier risk assessment – Sec 820.50(a)(1)	1 min 49 secs
Supplier risk assessment – Sec 820.50(2)	1 min 39 secs
Initial evaluation tool	1 min 30 secs
Supplier approval and the approval supplier list -Sec 820.50(3)	1 min 59 secs
Key elements of a supplier agreement Part 1	1 min 58 secs
Key elements of a supplier agreement Part 2	1 min 50 secs