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LAB 2: G(QC)LP in a Regulated Environment Description: This module introduces the participants to the basic concepts and requirements of GLPs in a regulated pharmaceutical laboratory. The issues that laboratory auditors focus on will also be discussed. Specific pharmaceutical regulatory requirements will be presented including requirements for investigation and handling out of specification conditions and current Good Automated Laboratory practices (GALP). Current guidelines published by the TGA and FDA will be reviewed. |
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| COURSE OUTLINE
INTRODUCTION 1. Introduction 2. Terminology 3. Compliance rules 4. Pharmacopoeias 5. cGMP references 6. Interpreting the rules 7. Review SPECIFICATION AND STANDARDS 8. Introduction 9. Specification 10. Reference standards 11. Preparing and standardising 12. GLP labelling GOOD AUTOMATED LABORATORY PRACTICES 13. Introduction 14. Raw vs Derived data 15. CFR Part 11 requirements 16. Recording raw data 17. HPLC 18. Raw data storage 19. Storing electronic data 20. Review COMPLETION OF NOTEBOOKS AND RECORDS 21. Introduction 22. Notebooks and worksheets 23. Completing records 24. Checking calculations 25. Archiving rules for records 26. Supporting records 27. Review SAMPLE AND DATA INTEGRITY 28. Introduction 29. Sample lifecycle 30. Altering records 31. Example 32. Significant figures 33. Review MANAGING OOS EVENTS 34. Introduction 35. Out-of-specification 36. OOS origin 37. GLP rules regarding OOS 38. OOS handling 39. Resolving OOS events 40. Handling OOT events 41. Review CONCLUSION 42. Summary |
COURSE OBJECTIVES
Students completing this course should be able to:
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