Date: Thursday, February 22, 2018
Time: 2:00 pm ET / 11:00 am PT / 7:00 pm GMT
Stability studies are required and conducted throughout all phases of the drug product life cycle. The regulatory requirements and challenges for stability studies can be quite different depending on the type of product being tested. Additional requirements can vary between early and late phase development. Therefore, some manufacturers have inadvertently made mistakes in the design of their stability testing program. Such mistakes may delay regulatory applications. Therefore, it is better to understand, follow and apply the full requirements of a new product stability testing specification from the onset or to correct an existing stability testing program to avoid future pitfalls and delayed regulatory submission.
Join an industry expert in this webinar for key insights on stability testing to support various stages of development and regulatory filings (IND, NDA and ANDA).
Register to learn more about:
- Understanding how to design and implement an effective stability testing program at each phase of development
- Registration stability protocol design, batch selection, and data submission
- Example stability protocols for registration
- Case studies, including an example of monitoring products for extractables and leachables
Wei Pan, PhD, RAC
Director, Stability & Analytical CMC
Catalent Pharma Solutions
Wei Pan is the Director, Stability & Analytical CMC at Catalent Pharma Solutions in Morrisville (RTP), North Carolina. Wei has 23 years of experience in the pharmaceutical industry providing analytical support in preformulation, method development, method validation, release and stability testing. Prior to her current appointment, Wei was Director, Strategy & Analytical CMC where she was responsible for analyzing regulatory requirement changes, industry trends and developing business strategies. She currently manages the Analytical Stability group and provides pharmaceutical development consultancy to customers on analytical strategies to support different stages of pharmaceutical development and regulatory filings (IND, NDA and ANDA). The Morrisville facility is center of excellence for stability studies within Catalent Pharma Solutions.