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Designing and Sustaining New and Existing Product Stability Testing Program

Start Date:
Thursday, 7 September, 2017
End Date:
Friday, 8 September, 2017 5:00pm
Speciality:
Business Practice
Website:
http://www.complianceonline.com/fda-drug-stability-testing-program-seminar-training-80320SEM-prdsm?channel=meetings4docs

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). 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. 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.

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 product's expiration dating. The employees who will benefit most include:Quality Control Analyst and ManagementSenior ManagementManufacturing Associates and ManagementShipping and Distribution PersonnelStability Testing Department Personnel and ManagementRegulatory AffairsNote: Use coupon code REFERRAL10 and get 10% off on registration.For Registration:http://www.complianceonline.com/fda-drug-stability-testing-program-seminar-training-80320SEM-prdsm?channel=meetings4docs

Location

San Diego,
California,
USA

Organizer Details

Conference organized by ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality, under a code of ethics, and with process discipline to ensure greater shareholder returns.Keeping things simple and straight forward, so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

Address:
2479 East Bayshore Road Suite 200
Phone:
+1-888-717-2436
Email:
referral@complianceonline.com

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