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Monday, June 26, 2017
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GLP: Stability Programs (GLP05)

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: Stability Programs
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This online course introduces the student to the requirements for stability programs, how they are reviewed, and their purpose. Also presented will be the basic requirements for scheduling tests. The course covers an overview of stability, stability protocols and schedules, storage conditions and test, stability results and shelf life, stability indicating methods, and a summary of the previously mentioned topics. Once all course requirements have been satisfied, the student will have immediate access to a certificate of completion in PDF format.

Benefits of Getting Certified at dinaris.org

The dinaris.org caters to individuals who are looking to upgrade their skills. For two decades, the Institute has been training employees from small businesses to large corporations. If you are looking for online training courses that are recognized across a wide range of pharmaceutical, healthcare, clinical research, and biotechnology industries, the dinaris.org has the training experience and methods in which you can rely on.

Whether taking our pharmaceutical training programs as a refresher course or as a new employee, students will find the online learning solutions at to be flexible, effective, and comprehensive. Our e-learning system comes with easy learning tools, such as high-quality animations, progress checks, voice-overs, and more, used to help our students understand the various learning concepts.

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: Stability Programs Course is Found in the Following Professional Certification Program(s):


Good Laboratory Practice (GLP) Professional Certification Program: The Good Laboratory Practice (GLP) Professional Certification Program comprises a set of seven courses designed to provide a comprehensive overview of good lab practice concepts and requirements in compliance w … Learn more

COURSE OUTLINE:


OVERVIEW STABILITY
1. Introduction
2. International stability testing guidance
3. Importance
4. Purpose of stability studies
5. Stability and container closure systems
6. Stability and degradation products
7. Forced degradation profile
8. Kinetic models
9. Review

STABILITY PROTOCOLS AND SCHEDULES
10. Introduction
11. Stability studies
12. Real-time studies
13. Accelerated studies
14. Significant changes
15. Importance of stability protocols
16. Stability protocols
17. Bracketing
18. Matrix design
19. Testing frequency
20. Review

STORAGE CONDITIONS AND TESTS
21. Introduction
22. Storage conditions
23. Stability trial storage conditions
24. Active raw materials
25. Finished dose forms
26. Expected tests
27. Presentation of results
28. Review

STABILITY RESULTS AND SHELF LIFE
29. Introduction
30. Stability trial design
31. Evaluation of results
32. Typical problems
33. Nominating shelf life
34. Calculating shelf life
35. Review

STABILITY INDICATING METHODS
36. Introduction
37. Stability indicating methods
38. Test methods I
39. Test methods II
40. Review

SUMMARY
41. Summary

COURSE OBJECTIVES:


–Describe the purpose and value of stability programs.
–List the different standards and cGMP requirements for stability programs.
–Set up a schedule for a stability program.
–List which stability indicating tests are expected for which dose forms.
–Assign a shelf life based on typical stability regression lines.
–State why methods need to be stability indicating in nature.

JOB POSTINGS:

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

Lab Assistant
Posted Date: 2017-06-23
Dignity Health – United States, CA, Bakersfield, 93399

Lab Tech II – Entry Level Chemist
Posted Date: 2017-06-22
Apex Life Sciences – United States, OH, Strongsville, 44136

Quality Assurance Administrator
Posted Date: 2017-06-25
WACO Products Inc. – United States, MD, Baltimore, 21276

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

See more QC QA Quality Lab Jobs


For more information on the dinaris.org’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 111-1111, or email Support@BioPharmaInstitute.com.

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