GLP Quality Control: Analytical Method Validation

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Program/Course ID: GLPQ01 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials/activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with validation QR barcode.

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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.

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Outline: INTRODUCTION 1. Introduction 2. Analytical method users 3. Regulatory standards 4. ICH standards 5. Summary 6. Review VALIDATION PHILOSOPHY 7. Introduction 8. Basic validation philosophy 9. Pre-requisites 10. Analytic methods 11. Performance parameters 12. Protocol structure METHOD PERFORMANCE PARAMETERS 13. Introduction 14. Performance parameters 15. Precision I 16. Precision II 17. Accuracy I 18. Accuracy II 19. Method capability 20. Method specificity 21. Linearity and Range 22. Sensitivity, LOD and LOQ I 23. Sensitivity, LOD and LOQ II 24. Sensitivity, LOD and LOQ III 25. Ruggedness/robustness 26. Review METHOD TRANSFER 27. Method transfer verification 28. Requirements 29. Review STABILITY INDICATING ASSAYS 30. Requirements 31. Review COMPENDIAL METHOD VALIDATION 32. Pharmacopoeial methods CONCLUSION 33. Summary		Objectives: List the key method performance parameters used in validation. Describe and calculate precision and accuracy. Describe and calculate selectivity and sensitivity. Describe and calculate linearity and range. Describe and calculate robustness and system suitability. State the differences between validation and verification of methods.

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Benefits of Training with Biopharma Institute

Immediate access to courses:	Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:	24/7 access to all course materials and assessments for 12 months.
Open enrollment:	No prior course prerequisites or work experience required.
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Flexible final assessments:	Multiple-choice questions can be taken repeatedly until a passing score is achieved.
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Comments: For quotes or invoices please provide the course(s) and number of students.	GLP Quality Control: Analytical Method Validation