21 CFR Part 820

21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation

Just because we designed the product correctly, and made the product correctly, doesn’t mean we are done. Handling, storage, distribution and installation of the product which isn’t done properly can also impact the quality and therefore put the customer at risk. Each of these items need to be addressed, even if they are not relevant to the product, we are making that should be noted, and an exclusion justified in the quality manual.

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CEU Credits: 0.1
Course Code: ELM-312
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 08/17/2021

Curriculum for this course

Overview
ISO, ICH and the FDA
Program organization
Program objectives
Definition of a medical device
Class I, II and III
Intended use
21 CFR 820 Timeline
1906 – The Jungle
1937 – Massengil Company
1957 – Thalidomide
1971 – Dalcon Corporation
1990 – FDA device recall report
A regulatory evolution
Course Introduction
Learning Objectives
Handling, Storage, Distribution and Installation
Handling and Storage Procedures – Part 1
Handling and Storage Procedures – Part 2
Distribution Procedures – Part 1
Distribution Procedures – Part 2
Installation

Conclusion

Final Exam

Results

Updated one instance of the term ICH listed as International Conference for Harmonisation to International Council for Harmonization..
V1.1

Author

Don Rackham

Associate Director QA Asterias Biosciences

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