Location: Attend Live Webinar
Dates: 10-Feb-2015: 10:00 AM PST
Duration : 90 Mins

Speaker: Kim Huynh-Ba

Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences.  She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S.

Course Description:

The main functions of the World Health Organization (WHO) are to provide develop and promote international standards with respect to biological, pharmaceutical and similar products.

In 2009, the WHO Expert Committee on Specifications for Pharmaceutical Preparations has issued Guidelines in WHO technical Report Series, No. 953, Annex 2 on Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical products. 

Course Objective:

This webinar will uncover key factors of this global guideline, assignment of climatic zones and global requirements for stability testing.

This guideline accommodates the ICH guidelines Q1A (R2) to provide structure for the stability program for global submission of new products. It includes specific information such as storage conditions, testing frequencies, and selection of batches.

Course Outline:

• Objective of the guidelines

• Principles of stability testing

• Stress testing requirements

• Batch selection for Drug Substance and Products

• Testing frequency

• Storage conditions according to climatic zones

• Requirements on Container closure system 

 Target Audience:

This session will benefit 

• Analytical chemists 

• Quality control scientists 

• Managers, directors 

• Quality Assurance professionals 

• Regulatory affairs 

• Researchers who are involved in developing and testing stability protocols and conducting stability testing. 

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Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

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