SeerPharma Pty Ltd :: DISCover web-based training :: GMP5: Documentation and Record Keeping

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GMP5: Documentation and Record Keeping

Description: The role of documentation in providing a history of manufacturing from supplier to customer. The requirements of Standard Operating Procedures (SOPs), Batch Processing Records, Quality Control Records and Logs are discussed and developed.

Price: $209 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

QUALITY ALERT
1. Quality Alert
2. Quality Alert II
3. What you will learn
4. Outcomes

NEED FOR DOCUMENTATION
5. Need for documentation
6. Documentation systems
7. Documentation and records
8. Review I
9. Review II

GMP DOCUMENTATION
10. GMP documentation
11. Specification
12. Inward goods
13. Production
14. Packaging
15. Quality Control
16. Master formulas

RECORD KEEPING
17. Record keeping
18. Changes to records
19. Review

CASE STUDY
20. The FixitKWIK problem
21. Records department
22. Dispensary
23. Formulations
24. Packaging
25. Quality Control
26. Interpreting
27. What is your conclusion?

SUMMARY
28. Summary I
29. Summary II

COURSE OBJECTIVES

Students completing this course should be able to:

State the GMP requirements for documentation
Explain the implications of not completing and certifying GMP documents
Complete batch records and associated supporting documents

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