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