Drug and Device Documentation:

Good Document Practices

 The regulatory environment imposes many requirements, not the least of them, the requirement to document specific activities. In the pharmaceutical and device industries, companies live or die by their documentation. A well structured and organized system of master document generation and control is imperative for the generation of rational data in compliance with regulatory submissions. The adage, "if its not documented, it didn't happen", is not far from the truth. This applies across the board whether it is in the GLP, GCP, GMP or in the "academic" research environment s.
This course will deal with the following content:
1. Who requires them, why, when?12. Significant/Insignificant change
2. Regulatory legal requirements.13. Records/Reports
3. ICH/ISO 9000 standards/impact14. Record keeping
4. Master Documents15. Review
5. Overview: major documents16. Batch/Material release
6. Organization/Structure17. Annual Reviews
7. Document Development process18. Trend Analysis
8. Examples19. Training
9. Change Control20. Automation
10. Permanent vs. Temporary21. Academic, Pre-Clinical, Clinical
11. Approvals/Reviews

 

© 1997 CPCS, Inc.