3-hr Virtual Seminar: GMP Compliant Stability Program for Pharmaceuticals
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Organizer :
Topic : Não classificadas;
Ciências da Engenharia; Keywords: Design
Description :
This 3-hr virtual session will cover pharmaceutical stability study requirements for Phase I, Phase II, Phase III clinical studies, show how to choose the right stability methods and specifications and review common pitfalls in pharmaceutical stability programs.
Why Should You Attend:
The Stability Program is a key component of Product Development. The time scale for a stability studies is relative long, ranging from 2-3 years and is very often on the Critical Path of the Product Development Project. Errors found in the study design, can result in major delays in the project filing. A well designed Stability protocol can result in significant savings during Product Development and after product approval.
Areas Covered in the Seminar:
- Overview of ICH and WHO requirements for Stability Programs.
- What are the Stability study requirements for Phase I, Phase II, Phase III clinical studies.
- What are the required Post Approval Stability studies.
- How to set up, conduct and complete a stability study.
- How to choose the right Stability methods and specifications.
- What are the common pit falls. 483s related to Stability programs.
3-hr Virtual Seminar: GMP Compliant Stability Program for Pharmaceuticals to be held in Online Webinar, Estados Unidos between 31 maio 2012 and 31 maio 2012. It covers specific areas of Não classificadas such as . Visit the website of the conference for more detailed information or contact the organizer for specific questions.
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