COURSE ID 599

Drug Product Stability and Shelf-Life

AVAILABLE Live
Date(s) and Time:
June 3, 2024 - June 6, 2024
12:30pm EDT - 5:30pm EDT
Duration: 18 Hours

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Dr. Pardeep K. Gupta

Early-Bird Offer

Limited Availability until May 14, 2024

$ 2600
Price
$ 2800
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Every drug product must undergo sufficient stability testing before it can be introduced to the market. While ICH has standardized and harmonized the stability testing process, there are still numerous challenges that need to be addressed to ensure that stability testing is conducted accurately. Inadequate stability testing can cause delays in product introduction, which is why all drug companies need to ensure that their programs meet acceptable standards.

This accredited training course is designed to provide participants with a comprehensive understanding of the science and principles behind stability testing for pharmaceutical, biotechnology, and cosmetic products. The course will cover kinetic approaches to chemical stability, the advantages, and limitations of accelerated stability testing, as well as degradation caused by chemical, physical, and microbiological factors.

The course will also cover data analysis, and practical aspects of stability testing, such as the role of packaging in stability. Considerable attention will be given to analytical methodology, data analysis, and data management. Participants will also receive a thorough review of current FDA Stability guidelines and ICH Guidelines on stability. The course will also include a workshop that provides participants with hands-on experience in data and statistical analysis.

Upon completion of this course, you will be able to:

  • Define the scientific and regulatory terminology in stability
  • Identity the stability protocols and data acceptable to FDA and ICH
  • Design a stability program
  • Analyze and interpret stability data and write stability report

The course will also include a workshop that provides participants with hands-on experience in data and statistical analysis.

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This course contains in-depth coverage of the science and practice of drug stability, and shelf life it is designed to benefit the following personnel:

  • QC/QA Managers/Supervisors
  • Product Stability Managers
  • Manufacturing Personnel
  • Regulatory Personal
  • Pharmaceutical Consultants
  • R&D Development Scientists and Managers

Personnel who routinely review stability data or reports would additionally benefit from this course by gaining a broader understanding of stability testing.

Course Instructor

Dr. Pardeep K. Gupta

Professor of Pharmaceutics, Philadelphia College of Pharmacy, University of The Sciences in Philadelphia (USciences)

Dr. Pardeep K. Gupta’s Courses

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