21 CFR Part 820 Subpart G – Production and Process Controls

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Description:

In this course you will learn about how each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.

Curriculum for this course:

Introduction

Overview	2 mins 10 secs
ISO, ICH and the FDA	1 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	1 mins 33 secs
Intended use	1 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

Production and Process Controls – Subpart G

Course introduction	45 secs
Learning objectives	1 min 05 secs
Specification, alert limits and action limits – Sec 820.70(a)	1 min 42 secs
Product and process control – Sec 820.70(b)	1 min 28 secs
Document and product design changes	1 min 32 secs
Personnel controls – Sec 820.70(d)	58 secs
Environmental and contamination control – Sec 820.70(c)(e)	1 min 18 secs
Buildings and facilities – Sec 820.70(f)	1 min 39 secs
Equipment controls – Sec 820.70(g)	1 min 21 secs
Custom & off the shelf equipment	1 min 42 secs
Equipment validation process – FAT	1 min 44 secs
Equipment validation process – SAT	51 secs
Maintenance schedule	48 secs
Calibration program	1 min 09 secs
Logbooks	1 min 55 secs
Maintenance action plan	1 min 27 secs
Maintenance schedule cards	1 min 37 secs
Manufacturing material / Line clearance – Sec 820.70(h)	1 min 30 secs