GLP: Sampling Plans
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2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:INTRODUCTION TO SAMPLING PLANS 1. Introduction 2. Purpose of sampling 3. Sampling requirements 4. Sampling steps 5. Sampling plans 6. Review READING ATTRIBUTE SAMPLING PLANS 7. Introduction 8. Defining an attribute 9. AQL I 10. AQL II 11. Parameters I 12. Parameters II 13. Parameters III 14. Reading plans I 15. Reading plans II 16. Reading plans III 17. Try some sampling plans 18. Review CGMP REQUIREMENTS FOR CHEMICALS 19. Introduction 20. Chemicals requirements 21. Supplier qualification 22. Chemical testing plans 23. Microbial testing plans 24. Review CGMP REQUIREMENTS FOR PRINTED MATTER 25. Printed matter requirements 26. Review SAMPLING TECHNIQUES AND POOLING 27. Introduction 28. Content uniformity 29. Liquids sampling issues 30. Pooling/compositing rules 31. Sampling frequency 32. Zero Acceptance Number 33. Review TARGETED SAMPLING PLANS 34. Introduction 35. Limitations 36. Targeted sampling 37. Water samples 38. Sampling points 39. Review CONCLUSION 40. Summary | Objectives:Describe the considerations for setting up sampling plans. Read and interpret an attribute sampling plan. List special cGMP requirements for sampling chemicals. List special cGMP requirements for sampling printed matter and components. State the cGMP expectations for sample protection and pooling. Set up targeted sampling plans for a purified/WFI water system. | |
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