21 CFR Part 820 Subpart I – Nonconforming Products
Description:
In this course you will learn about nonconforming product and product that fails to meet a requirement, need, expectation or obligation and how each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.
Curriculum for this course:
Introduction
| Overview | 2 mins 10 secs |
| ISO, ICH and the FDA | 1 min 30 secs |
| Program organization | 1 min 20 secs |
| Program objectives | 1 min 25 secs |
| Definition of a medical device | 1 min 50 secs |
| Class I, II and III | 2 mins 11 secs |
| Intended use | 1 mins 33 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 |
Nonconforming Products – Subpart I
| Course introduction | 1 min 10 secs |
| Learning objectives | 56 secs |
| Nonconforming products – Sec 820.90 | 1 min 31 secs |
| Extend to other systems | 1 min 55 secs |
| Out of specification (OOS) | 1 min 25 secs |
| Management of nonconformance’s | 1 min 48 secs |
| The NCR process | 1 min 30 secs |
| Disposition decision | 1 min 39 secs |
| The material review board | 1 min 50 secs |
| The QA manager | 1 min 52 secs |
| Deviations | 1 min 22 secs |
| Deviation example | 1 min 40 secs |
| Planned deviations | 1 min 15 secs |
| Deviation systems | 1 min 55 secs |
Conclusion
Final Exam
Certification
Author:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-309 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
All you need to know about non-conforming products explained in an easy way.
Another great course in the Part 820 series, quality delivery as always.
A no-brainer for anyone working in the device world.
Related courses:
21 CFR Part 820 Subpart A – General Provisions
Course code: ELM-301
21 CFR Part 820 Subpart B – Quality System Requirements
Course code: ELM-302
21 CFR Part 820 Subpart C – Design Controls
Course code: ELM-303
21 CFR Part 820 Subpart D – Document Controls
Course code: ELM-304
21 CFR Part 820 Subpart E – Purchasing Controls
Course code: ELM-305
21 CFR Part 820 Subpart F – Identification and Traceability
Course code: ELM-306
21 CFR Part 820 Subpart G – Production and Process Controls
Course code: ELM-307
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