Title: PW-Course-Import-Test

Course Introduction
  About this Course
  Meet Your Instructor
  Course Syllabus
  Get to Know Canvas
  Navigating the Course
  Learning Community: Introduce Yourself
Module 1: Introduction to Medical Device Quality Systems
  Module 1 Overview: Intro to Medical Device Quality Systems
  History of Quality Regulations
  The Medical Device Enforcement Structure
  Learning Community: Enforcement Actions
  Module 1 Additional Resources
  Module 1 Conclusion
Module 2: Design Controls
  Module 2 Overview: Design Controls
  Design Controls for Medical Devices (Subpart C)
  Learning Community: Design Controls
  The Design Control Process
  Learning Community: Design Control Process
  Design Validation and Verification
  Learning Community: Design Verification and Validation
  Design Change
  Module 2 Conclusion
Module 3: Document Control
  Module 3 Overview: Document Control
  Document Controls for Medical Devices (Subpart D)
  Learning Community: Document Control
  Non-Compliance with Document Control
  Learning Community: Document Control, Warning Letter
  Electronic Records Document Control
  Learning Community: 21 CFR Part 11 vs 21 CFR 820.40
  Module 3 Conclusion
Module 4: Production and Process Controls
  Module 4 Overview: Production and Process Controls
  Why are Production and Process Controls Necessary?
  Learning Community: Subpart G
  Learning Community: Acceptance Activities
  Learning Community: Non-Conforming Product
  Module 4 Conclusion
Module 5:CAPA
  Module 5 Overview: CAPA
  What is CAPA and Why Is It Part of CFR 820?
  Learning Community: CAPA
  Module 5 Conclusion
Module 6: Quality Records
  Module 6 Overview: Quality Records
  Why Are Medical Device Records Part of the Regulation?
  Learning Community: Quality Records
  Why are Records Retrieved and Reviewed?
  Learning Community: Non-compliance to Quality Records
  Module 6 Conclusion
Module 7: Internal Audit Programs
  Module 7 Overview: Internal Audit Program
  What is an Internal Audit?
  How can the Medical Device Industry Stay Prepared with Respect to FDA Expectations?
  What are the Benefits of Conducting Internal Audits?
  Learning Community: Internal Audits
  Module 7 Additional Resources
  Module 7 Conclusion
Module 8: ISO 13485
  Module 8 Overview: ISO 13485
  Why is ISO 13485 Important?
  Learning Community: 21 CFR 820 and ISO 13485
  Learning Community: FDA vs. ISO
  What are the Regulatory and Business Impacts of ISO Certification Audits vs. FDA Investigations?
  Module 8 Additional Resources
  Module 8 Conclusion
Final Exams
  Final Exams Instructions
  Final Exams Notes for Instructor-DO NOT PUBLISH