Course Content

5 Quality Systems Regulation & GMP

Course Overview

1 Introduction

2 Safety & Effectiveness

3 Regulatory Pathways

4 Clinical Trials

• 5 Quality Systems

Video
Slides
Quiz
Worksheet
References

6 Intl Regulation

References

Glossary

Summary

Provide FEEDBACK

• What are the scope, content, and requirements of the
  
• Quality Systems Regulation (QSR) and of the
  
• Good Manufacturing Practice(GMP) regulation
• What are Design controls?
  
• How is a Device Master Record used?
  
• What are the Documentation Requirements?
  
• How is Change Control handled?
  
• Whar are the Post-Market Surveilance requirements?
  
• What are relevant International Quality Standards?
  

Content

Play video

1. Jan Pietzsch on Quality Systems
2. Michelle Paganini on Quality Systems

Slides (PDF)

Speakers Biographies

Jan Pietzsch

Michelle Paganini

Additional Materials

Assessment Quiz

Worksheet (pdf)

References (doc)