An Introduction to Medical Device Validation – Part 1
Description:
This training program will be beneficial to all personnel directly involved in medical device validation, as well as new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with validation or interact with regulatory agency inspectors to rationalize or defend validation programs will also benefit from taking this course. No experience of validation is necessary though some knowledge of processes would be beneficial.
Curriculum for this course:
Introduction
| Course Overview | 1 min 01 secs |
| Learning Objectives | 1 min 31 secs |
| Who Should Take This Course? | 1 min 11 secs |
Module 1: The Starting Point
| Validation Vs Verification | 2 min 05 sec |
| Example of Verified and Validated | 1 min 45 secs |
| Product Life Cycle | 1 min 10 secs |
Module 2: Regulatory Requirements
| USA – 21 CFR Part 820 | 1 min 12 secs |
| EU MDR 2017/745 | 1 mins 29 secs |
| ISO 13485 | 1 min 02 secs |
| GHTF 2004 Guidance – Process Validation | 1 min 39 secs |
Module 3: Devastating Consequences of Non-Compliance
| 2009 – Poly Implant Prothèse (PIP) Breast Implants | 1 min 01 secs |
| 2010 – DePuy Hip Replacement Recall | 1 min 13 secs |
| 2012 – Stryker Modular-Neck Hip Stem Implants Recall | 1 min 33 secs |
| 2012 – Batteries of Pacemakers and Implantable Defibrillators | 1 min 06 secs |
| 2019 – Medtronic’s Product Recall of Implanted Cardiac Pacemakers | 1 min 19 secs |
| 2019 – Injectable Cosmetic Treatments | 1 min 27 secs |
Module 4: Case Studies
| Case Study One: Duodenoscope | 1 min 10 secs |
| Case Study Two: LVAD Pump Stoppage | 1 min 01 secs |
| Case Study Three: Pacemaker Hack | 1 min 25 secs |
| Case Study Four: FDA Warning Letter (21 CFR Part 820.75) | 1 min 09 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-156 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
The explanation of validation vs verification with the life preserver example is gold, just play this part of the course next time your team has this ongoing debate.
The devastating consequences of non-compliance and the cases studies are spot on and make this topic very real for the learner.
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
ISO 13485:2016 – Chapter 1-3: Introduction
ISO 13485:2016 – Chapter 5: Management Responsibility
ISO 13485:2016 – Chapter 6: Resource Management
ISO 13485:2016 Product Realization (Chapter 7 – Part A)
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