MD-Q 2: Documentation and Records

Description: The development, implementation and control of documentation and records provide the foundation of a Quality Management System. It also provides evidence of compliance with ISO 13485 standards and the FDA CFR 820 Quality System Regulations (QSRs). This module will introduce you to medical device documentation and records requirements and their controls.

Price: $209 (AUD)

INTRODUCTION
1. Welcome
2. Module objectives
3. Reviews and assessments

QUALITY SYSTEM DOCUMENTATION
4. Overview
5. Types of documentation
6. Scope and complexity of documentation
7. Document hierarchy
8. ISO/QSR documentation requirements
9. Quality policy & objectives
10. Quality manual
11. SOPs for QS elements
12. SOPs for measurement, analysis and improvement
13. Design control procedures
14. Typical structure of SOPs
15. QMS records
16. Activity
17. Topic review

PRODUCT RELATED DOCUMENTATION
18. Production control documentation
19. Device Master Record
20. Location of DMRs
21. Device history records
22. Topic review

DOCUMENTATION AND RECORD CHANGE CONTROL
23. Overview
24. Regulatory requirements - document control
25. A document control system
26. Change control procedure
27. Record control
28. Topic review

CONCLUSION
29. Final Assessment

• List the objectives of thorough quality system documentation
• Explain the elements of quality system documentation requirements
• Discuss the requirements of a Device Master Record
• Discuss the requirements of a Device History File
• List the regulatory requirements for documentation
• Describe record and change control procedures

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