2020 - Designing and Sustaining New and Existing Product Stability Testing Program

This seminar will help the attendee gain a better understanding of the requirements of the FDA’s Drug Stability Guidelines that is stipulated for new, existing and modified drug products that have an existing or new IND or NDA submission.
This seminar will also benefit people within the Pharmaceutical, Biotechnology or Medical Device industries that are currently have a stability testing program but do not know how to maximize the use of their data for extending their product’s expiration dating.
This seminar will provide the detailed requirements applicable to the FDA’s and 21CFR 514.1(b)(5)(x) expectations which states that “an applicant should submit data from stability studies that have been completed as well as information about studies that are underway to substantiate the request for a specific expiration date and provide information on the stability of the drug products” FDA’s Guidance for Industry. For this reason, it is important to have clarity and understanding of how to apply this regulation prior to the initiation of a new product stability testing program which includes the protocol design, testing, storage, data management, trending and expiration dating extrapolations and expectations for products in a new or existing IND or NDA application process.