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Home » GLP: Stability Programs

GLP: Stability Programs (GLP05)

Certification Training
 
Rated 4.11/5
9 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Good Laboratory Practices.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GLP: Stability Programs
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


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


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.

The GLP: Stability Programs Course is Included in the Following Professional Certification Programs:


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 laboratory practice concepts and requirements in compl ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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