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Thursday, December 12, 2019
Home » GLP: Stability Programs

GLP: Stability Programs (GLP05)

Certification Training
 
Rated 4.11/5
9 reviews
Duration: 2 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 2
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

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

Availability: Immediately available 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, the student will have immediate access to a certificate of completion in PDF format.

Benefits of Getting Certified at BioPharma Institute

The BioPharma Institute 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 BioPharma Institute 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) 424-6576 or send us an email at support@biopharmainstitute.com 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.

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.

All Courses in the Good Laboratory Practices Catalog:


GLP: Introduction to QC: This online course introduces students to the basic requirements and concepts of Good Quality Control Laboratory Practices. It will review the standards used in the industry and specify QC requirements and defi ... Learn more

GLP: QC in a Regulated Laboratory: This online course introduces students to the basic requirements and concepts of quality control in a regulated pharmaceutical laboratory. It discusses issues that laboratory auditors focus on. Also presented w ... Learn more

GLP: Basic Statistics for QC Laboratories: This online course covers a number of practical and essential statistical techniques that are needed for the analyst working in a laboratory setting. Students will learn how and when to apply techniques to data ... Learn more

GLP: Sampling Plans: This online course discusses the unique problems found in pharmaceutical production, whether inactive or active chemical materials, unprinted or printed packaging materials, process water, in-process materials, ... Learn more

GLP: Stability Programs: 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 cov ... Learn more

GLP: Microbiology and QC: This online course provides an introduction to the basic requirements and concepts of quality control for microbiological testing laboratories operating under good laboratory practice (GLP) guidelines. The cour ... Learn more

GLP: Microbiology Laboratory Techniques: This online course describes a number of fundamental procedures and techniques that are used regularly in laboratories dealing in microbiology. The course covers topics such as biohazard cabinets and laminar fl ... Learn more

GLP Quality Control: Analytical Method Validation: 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 ... Learn more

GLP Quality Control: IQ/OQ and Calibration of Lab Equipment: This course is to be taken online, and covers the requirements for the qualification of laboratory instruments, including Performance Qualification (PQ), Operational Qualification (OQ), and Installation Qualifi ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password and receipt of payment 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 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, 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 offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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