CEU Credits: 0.1
Course Code: ELM-156
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Course Overview
Learning Objectives
Who Should Take This Course?
Validation Vs Verification
Example of Verified and Validated
Product Life Cycle
USA – 21 CFR Part 820
EU MDR 2017/745
ISO 13485
GHTF 2004 Guidance – Process Validation
2009 - Poly Implant Prothèse (PIP) Breast Implants
2010 - DePuy Hip Replacement Recall
2012 - Stryker Modular-Neck Hip Stem Implants Recall
2012 - Batteries of Pacemakers and Implantable Defibrillators
2019 - Medtronic’s Product Recall of Implanted Cardiac Pacemakers
2019 - Injectable Cosmetic Treatments
Case Study One: Duodenoscope
Case Study Two: LVAD Pump Stoppage
Case Study Three: Pacemaker Hack
Case Study Four: FDA Warning Letter (21 CFR Part 820.75)
Conclusion
Final Assessment
Certification