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
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