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Establish Change Control for Pharmaceutical Stability Program

3/6/2014 10:00 AM - 11:30 AM

Why Should You Attend:

New medicines are developed every day to meet medical needs and improve quality of life. Stability program is necessary for product registration, and changes to the product require additional stability studies. As part of GMP requirements, pharmaceutical companies must establish a change control system to monitor any change to the product, process or package.

This session will discuss what type of changes exist in the product life cycle and how these changes can affect the stability profile of the pharmaceutical product through expiry. The instructor will also discuss potential risks to manage these changes to the stability program.

Learning Objectives:

Upon completion of this session, attendees will understand the factors that would affect the stability program and how to establish the change control to support product marketing strategies. This session will also discuss the observations and infractions due to lack of change control system of the program.

Areas Covered in the Webinar:

-Stability is defined as a critical quality attribute

-What type of CMC changes in the life cycle of a drug product

-How changes affect the stability profile of the product throughout the expiry

-Distinguish between minor and major changes of a registration stability program

-Determine potential risks to manage these stability changes

Who will benefit:

-Quality Control managers and personnel

-Pharmaceutical scientists

-Manufacturers of raw material and ingredients

-Analysts and lab managers

-QA managers and personnel

-Regulatory affairs

-Compliance scientists

Instructor Profile:

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. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.

Learn More: Establish Change Control for Pharmaceutical Stability Program

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