21 CFR Part 820 Subpart G – Production and Process Controls

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
Conclusion
Final Exam
Certification
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