Sci & Risk Based Stab Practices in Pharma Devel. Part III: Leveraging Knowledge to Design Studies
February 17, 2022
Webinar
Location: Virtual
Venue: GoToWebinar
Science & Risk Based Stability Practices in Pharmaceutical Development Part III: Leveraging Knowledge to Design Appropriate Stability Studies
Thu, Feb 17, 2022 11:00 AM - 12:00 PM EST
Presented by the Science & Risk Based Stability Working Group
Sponsored by the Analytical Leadership Group
Speakers
- Jackson Pellett, Genentech
- Paul Gerst, Pfizer
Stability data that is collected throughout development should help inform downstream decisions and additional stability study designs to ensure the appropriate attributes are being investigated. This webinar will further enhance the stability life cycle concept throughout development by illustrating how data from early development and clinical stability studies can be leveraged to design appropriate late stage and/or ICH stability studies.
The following learning points will be discussed:
- Conducting Stability Risk Assessments
- Using available stability data to select product packaging
- Utilization of lean stability approaches
- Establishing a product shelf-life
- Justifying specifications using stability data
This webinar is open to the general public. Membership in the IQ Consortium is not required for registration.