Stability Testing Of Pharmaceutical Products From Regulatory Perspective
Mohammad has a unique blend of both technical and regulatory experience and qualifications he gained from his +18 years’ experience in the pharmaceutical industry. After graduating in pharmaceutical science from the University of Cairo, He has held posts in the fields of R&D and production of pharmaceutical dosage forms and as a contract manufacturing coordinator then, after completing postgraduate certificate in management from the American university in Cairo (AUC). He has senior management roles in business development in pharmaceutical industry including opening new markets in local & export markets which allowed him to deal with different regulatory health authorities & business environments.
He successfully leaded his team in cooperation with colleagues from other departments within the companies in many market access projects in many African countries, ASEAN, GCC and other Middle East Countries.
Also, He was responsible for establishment of supply chain department in many pharmaceuticals Co. leading planning, local & foreign purchasing and warehouse functions in the company.
This webinar gives a fundamental knowledge of stability testing requirements for establishing storage conditions and expiration of pharmaceutical products.
Stability data form an important element of pharmaceutical regulatory submissions. This webinar will provide participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements.
Also, they will be able to determine the types and conditions of stability testing required for different types of pharmaceutical products.
During the webinar, we will discuss all factors that are inherent to the stability testing and that any changes to these factors post-approval will lead to repeating the stability testing for variation approval.
Areas Covered
- The purpose of performing stability testing in the pharmaceutical industry
- Factors affecting the stability of pharmaceutical products
- ICH climatic zones
- ICH requirements for stability testing
- Different types of stability testing and when it is required
- Developing stability testing protocol
- Most common inquiries raised by the reviewers regarding the stability of data
- Recommended labeling statements for storage conditions
Course Level - Basic/Intermediate
Who Should Attend
- Stability Personnel
- Methodology Personnel
- Quality Control Personnel
- Product Development Personnel
- Regulatory Affairs Personnel
Why Should You Attend
- To be aware of the purpose and objective of performing the stability testing
- To be aware of the regulatory guidelines that regulate the stability testing
- To know different types of stability testing
- To know how to determine the storage conditions and its relevant labeling statement
- To understand what stability testing is required following changes to a product
- To know how to place the stability results in the submission
Topic Background
Stability Testing is an important part of the development and marketing phase of a drug product or active pharmaceutical ingredient. The knowledge obtained is used to determine the storage conditions (temperature/moisture), the retest period for active pharmaceutical ingredients, the maximum expiration dating period (shelf life) of drug products, the correct packaging to protect the product, and the transport conditions.
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$200.00
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