21 CFR Part 820 Subpart K: Labeling and Packaging Control
Description:
Labeling may seem like a relatively simple topic, bit it is a very complicated topic with regards to medical devices. Before we go too far, let’s start with the basic definition of “label”. The term “label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
Curriculum for this course:
Introduction
| Overview | 1 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 | 1 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 | 1 min 10 secs |
| 1957 – Thalidomide | 58 secs |
| 1971 – Dalcon Corporation | 1 min 48 secs |
| 1990 – FDA device recall report | 1 min 24 secs |
| A regulatory evolution | 1 min 30 secs |
Labeling and Packaging Control – Subpart K
| Course Introduction | 1 mins 15 secs |
| Learning Objectives | 1 mins 29 secs |
| Labeling and Packaging Control – Sec 820.120/130 – Part 1 | 1 mins 17 secs |
| Labeling and Packaging Control – Sec 820.120/130 – Part 2 | 1 mins 22 secs |
| Label Integrity | 1 mins 11 secs |
| Stability Studies – Various Time Points | 58 secs |
| Stability Studies – Accelerated Studies | 1 mins 23 secs |
| Stability Studies – Closed and Open Container | 1 mins 31 secs |
| Transportation Studies – Procedure | 1 mins 41 secs |
| Transportation Studies – Simplified | 1 mins 27 secs |
| Labeling Operations – Static Vs Dynamic | 1 mins 39 secs |
| Labeling Operations – Handled Differently | 1 mins 51 secs |
Conclusion
Final Exam
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-311 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
A great insight into labeling and packaging control and how it aligns with 21 CFR Part 820.
A key training resource for our organization to bring new hires up to speed fast with Part 820
A superb refresher training for our staff to ensure we align with the regs.
Related courses:
21 CFR Part 820 Subpart A – General Provisions
21 CFR Part 820 Subpart B – Quality System Requirements
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
21 CFR Part 820 Subpart E – Purchasing Controls
21 CFR Part 820 Subpart F – Identification and Traceability
21 CFR Part 820 Subpart G – Production and Process Controls
21 CFR Part 820 Subpart H – Acceptance Activities
21 CFR Part 820 Subpart I – Nonconforming Products
21 CFR Part 820 Subpart J – Corrective and Preventive Action
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