Stability studies are a critical part of the drug development process and are essential for drug product marketing approval.
Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market. During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs. At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration. After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.
- This webinar will address the principles and practices of stability studies in the drug development process.
- It will discuss the framework of the FDA cGMP guidelines as expressed in 21CFR 211 which will help pharmaceutical analysts to understand the process.
- It will also provide a comprehensive review of the ICH and WHO stability guidelines and discuss the strategy used in stability protocols design to support global registration.
Wei Pan, Ph.D. RAC, Senior Manager, Catalent Pharma Solutions
Dr. Pan is currently a senior manager in the development and clinical services business unit in the Research Triangle Park, NC facility. She received her Ph.D. in inorganic chemistry from University of Miami. She also has a Regulatory Affair Certification by the Regulatory Affair Professional Society (RAPS) with a focus on the analytical CMC requirements to support different regulatory filings (IND, NDA and ANDA). Dr. Pan has over 14 year of pharmaceutical industry experience. She joined Catalent Pharma Solutions (then Magellan Laboratories) in 1999. She has worked in the analytical CMC areas including preformulation, method development, method validation, release and stability testing of drug substances and drug products of a variety of dosage forms. In her current role as a senior manager, she is responsible to manage the stability group and the product ventures group in RTP. The RTP facility is the center of excellence for stability testing designated by Catalent Pharma Solutions.
Kathy Waddle, Director, Stability QC Biology, Catalent Pharma Solutions
Kathy Waddle is the Director of Stability, Quality Control, and Biology for Catalent Pharma Solutions in the development and clinical services business unit in the Research Triangle Park, NC facility.
She has a Master degree in Pharmaceutical Chemistry from the Medical College of Virginia, Virginia Commonwealth University. With over 25 years in the pharmaceutical industry, Kathy has previously worked at Eli Lilly, Burroughs- Wellcome, and Sphinx Pharmaceutical. She joined Catalent in 1994. In her current role she is responsible for the stability, quality control, microbiology, bioassay and biosafety departments at the Catalent RTP facility.
Who Should Attend?
Managers, Directors, Vice President’s of small and large Pharma that are working in product development of all dosage forms
Catalent Pharma Solutions
Catalent Pharma Solutions is an industry leader with nearly 20 years of experience and resources in conducting stability testing for all types of commercial and premarket drug products, from placebos to controlled drugs. Catalent has a proven record serving the pharmaceutical and biotechnology industries having successfully completed thousands of stability studies at all ICH and WHO conditions, and at customer specific conditions.
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