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Monday, June 26, 2017
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GLP Quality Control: Analytical Method Validation (GLPQ01)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00

dinaris.org LogoTraining Program: GLP Quality Control: Analytical Method Validation
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

A fundamental QC requirement, both for GMP inspection of laboratories and product registration, is the analytical test method validation. Worldwide GMP auditing trends are currently focusing on Good Laboratory Practices and analytical method validation in particular.

This course is designed to provide students with procedures and techniques for the control, analysis, and validation of analytical test methods. The program covers such topics as performance parameter definitions, their acceptance criteria, and how to set up for linearity studies, precision, cost-efficient accuracy, etc. Also presented are industry requirements for documenting method validations (FDA, TGA, and ICH), as well as techniques and tips for method transfer. Once all course requirements have been satisfied, students will have immediate access to a certificate of completion in PDF format.

Benefits of Getting Certified at dinaris.org

Through the years, the dinaris.org has compiled a comprehensive offering of courses which can be taken online, books, recorded seminars, live seminars, and other training implements used to teach the various aspects of particular job functions and applications found within the pharmaceutical, biotechnology, and healthcare industries. We have proudly provided solutions and online training to companies and individuals working in thousands of US and overseas corporations.

With expertise in managing large training projects, our Institute strives to give professionals the assistance they need with uncovering fresh discoveries and furthering their understanding of the industry and the peripheral technologies within.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The GLP Quality Control: Analytical Method Validation Course is Found in the Following Professional Certification Program(s):


Quality Control in the Laboratory Professional Certification Program: The Quality Control in the Laboratory Professional Certification Program is an online program offered by dinaris.org. The program offers to provide quality information regarding current standards govern … Learn more

COURSE 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

COURSE 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.

JOB POSTINGS:

5700 QC QA Quality Lab jobs found.
Displaying jobs #1-4.

Quality Engineer
Posted Date: 2017-06-25
Bartech Group – United States, KY, Bowling Green, 42101

Technician /QA Equipment Custodian
Posted Date: 2017-06-25
MET Laboratories, Inc. – United States, CA, Union City, 94587

Customer Service Rep/Quality Assurance Monitor
Posted Date: 2017-06-23
CBSI Financial & Marketing Services – United States, NY, Harrison, 10528

Quality Technician
Posted Date: 2017-06-24
Job Impulse – United States, SC, Greenville, 29610

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