Medical Device: US Quality System Requirements (21 CFR PART 820)

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Program/Course ID: MDU2 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Wednesday, April 15, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: INTRODUCTION 1. Welcome 2. Introduction 3. Reviews and Assessments QUALITY SYSTEMS 4. Overview of 21 CFR 820 5. Quality System Definition 6. More on Quality Systems 7. QSRs 8. Implementation 9. Quality System Linkages ROLES AND RESPONSIBILITIES 10. Overview 11. Management 12. Management Representative 13. Company Personnel 14. Review PRODUCTION ASSURANCE 15. Overview 16. Product Assurance 17. Design Control Overview 18. Design Control 19. Purchasing Control 20. Identification/Traceability 21. Process Control 22. Control of Production Processes 23. Process Validation 24. Device Labeling 25. Handling QUALITY ASSURANCE 26. Overview 27. Acceptance Activities 28. Nonconforming Products 29. CAPA 30. Servicing and Repair 31. Statistical Techniques 32. Review PRODUCT DOCUMENTATION 33. Overview 34. Device Master Record 35. Device History Record 36. Complaint Files 37. Review FDA INSPECTION 38. Introduction 39. Inspection Procedure 40. FDA Inspection Guidance CONCLUSION 41. Summary		Objectives: State how 21 CFR 820 relates to the medical device industry. Identify the requirements of the quality system. Explain the role of key stakeholders in establishing and maintaining a quality system. Identify what documentation is required for quality system.

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Comments: For quotes or invoices please provide the titles of the course(s) and number of students.	Medical Device: US Quality System Requirements (21 CFR PART 820)