- TypeSeminar
- Location Orlando, Florida, United States
- Date 17-11-2016 - 18-11-2016
Education/Teaching/Training/Development
Medical/Healthcare/Hospital
New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, some manufacturers of new drug products have made inadvertent mistakes in the design of their new drug stability testing program. Such mistakes may ultimately delay the new, existing or modified product IND or NDA application process due to the data that was presented to the FDA (i.e. Relevant aspects of the stability testing program requirement may have been omitted by the drug manufacturers).
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It is better to understand, follow and apply the full requirements of a new product stability testing requirement from the onset or to correct an existing stability testing program so as to avoid future pitfalls and delayed IND or NDA submission process by the FDA. Having produced a new or existing product, knowing the appropriate way to design and perform the stability testing of the new product which is a prerequisite for setting the product's expiration date and possible extension of the expiration date is critical. Some drug product manufacturers have made mistakes in the past whereby a new product that was manufactured appropriately did not have a good stability testing plan or program hence it delayed the product's ability to have an approved IND or NDA submission.
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A mistake of this sort has also been made by drug manufactures that resulted in a 483 or Warning letter by the FDA. Knowing how to approach the design of a new product stability program at the onset of the new product design or during an existing product testing is important and will save a company time and cost in moving the product to the next phase.
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Charity Ogunsanya, CEO and Founder, Pharmabiodevice Consulting LLC
Course Id: 80320SEM
1 Orlando, FL November 17-18, 2016
LEARNING OBJECTIVES:
This seminar will help the attendee gain a better understanding of the requirements of the FDAâs 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 productâs expiration dating.
This seminar will provide the detailed requirements applicable to the FDAâs and 21CFR 514.1(b)(5)(x) expectations which states that âan 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 productsâ FDAâs 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.
WHO WILL BENEFIT:
The Seminar will benefit people within the pharmaceutical, biotechnology or medical device industries that currently have a stability testing program but are not savvy about maximizing the use of their data for extending their productâs expiration dating. The employees who will benefit most include:
Note:
Use coupon code NB5SQH8N and get 10% off on registration.
For Registration:
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