21 CFR Part 820 Subpart M – Records
Description:
Records are what we create to provide the evidence that we are following our procedures; therefore, they are extremely critical. It is important to remember that the records we generate must be admissible in court and therefore good documentation practices (GDP) are also important. Record alterations are considered a deliberate misrepresentation of facts. When an alteration is discovered during litigation it seriously undermines the ability to defend the claim of regulation compliance.
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 |
Records -Subpart M
| Course Introduction | 1 min 20 secs |
| Learning Objectives | 1 min 50 secs |
| General Requirements | 1 min 02 secs |
| Good Documentation Practices | 1 min 55 secs |
| Signatures and Initials – Legally Binding | 1 mins 11 secs |
| Signatures and Initials – Verification | 58 secs |
| Signatures and Initials – Signature Cards | 1 min 49 secs |
| Signatures and Initials – Asian Countries | 1 mins 31 secs |
| Date and Time | 1 min 30 secs |
| Date and Time – Backdating | 1 min 01 secs |
| Handling Errors | 1 min 22 secs |
| Handling Errors – Blank Spaces | 1 min 40 secs |
| Significant Figures and Rounding of Numbers | 1 min 09 secs |
| Pagination | 1 min 18 secs |
| Footnoting | 1 min 29 secs |
| Records | 1 min 05 secs |
| Record Retention | 1 min 39 secs |
| Record Retention – DMR & DHR | 1 min 19 secs |
| Quality System Record | 1 min 30 secs |
| Complaints – Uniform & Timely | 1 min 40 secs |
| Complaints – MDR | 50 secs |
| Complaints – Reporting | 1 min 11 secs |
| Complaint Process | 1 min 39 secs |
| Complaint Trending | 1 min 22 secs |
| Complaint Closing | 1 min 30 secs |
Conclusion
Final Exam
Certification
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-313 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
A key subpart to Part 820 to ensure the integrity of our medical device records.
A must do course for all our manufacturing staff.
Clear concise and to the point, this was a great refresher for me.
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
21 CFR Part 820 Subpart K: Labeling and Packaging Control
21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation
Talk to us
Find out how we can help you bring your life science training to the next level.