BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T132058Z UID:b5cf934d-e357-4bb1-be7e-6c9fef94fe25 DTSTART:20210217T080000 DTEND:20210218T080000 CLASS:PRIVATE DESCRIPTION:\n
 \;
\n\n*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
\nREGISTER TODAY! \;
&nbs p\;
\n\nNew or existing modified drug Stability Testing Program'\;s regulations/requirements stipulated by th e 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 i n the design of their new drug stability testing program. Such mistakes ma y ultimately delay the new\, existing or modified product IND or NDA appli cation process due to the data that was presented to the FDA (i.e. Relevan t aspects of the stability testing program requirement may have been omitt ed by the drug manufacturers). It is better to understand\, follow and app ly the full requirements of a new product stability testing requirement fr om 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 e xtension of the expiration date is critical. Some drug product manufacture rs have made mistakes in the past whereby a new product that was manufactu red appropriately did not have a good stability testing plan or program he nce it delayed the product'\;s ability to have an approved IND or NDA s ubmission. 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 approa ch the design of a new product stability program at the onset of the new p roduct 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.
\nThis seminar will provide a great resource to Pharmaceutical\, Biot echnology\, Diagnostics\, Cell Therapy\, Drugs\, Biologics\, OTC\, Radio-p harmaceutical\, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product'\;s regulatory filing requirements as well as the determination of the shelf life or exp iration date of the product. This is an important part of every business f inal bottom line or indirectly relationship to their supply and warehouse chain (how long the product can be stored before it can be discarded). Und erstanding how to design and implement an effective stability testing prog ram following the regulatory guidelines will allow the product to be manuf actured\, tested\, released\, adequately stored and effectively tested for stability and ultimately used through its actual end point based on the p roduct'\;s potency. This will eliminate potential loss of product and b usiness income by manufacturers of product (i.e. when a potent product is inadvertently discarded due to a poorly designed stability testing program ) which ends up impacting the products'\; regulatory filing status or a product'\;s Regulatory Filing/Application. The focus of this seminar w ill create a detailed process that will guide the attendees in the right d irection in the planning of a new or existing product'\;s stability tes ting plan\, program\, protocol\, handing and utilizing the data\, setting the shelf life as well as the applicable regulatory requirements. p>\n \;\n\n
This semin ar will help the attendee gain a better understanding of the requirements of the FDA&rsquo\;s Drug Stability Guidelines that is stipulated for new\, existing and modified drug products that have an existing or new IND or N DA submission.
\n\nThis seminar will also benefit people within the Pharmaceutical\, Biotechnology or Med ical 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&rsquo\;s expiration dating.
\n\nThis seminar will provide the detailed requirements applicable t o the FDA&rsquo\;s and 21CFR 514.1(b)(5)(x) expectations which states that &ldquo\;an applicant should submit data from stability studies that have been completed as well as information about studies that are underway to s ubstantiate the request for a specific expiration date and provide informa tion on the stability of the drug products&rdquo\; FDA&rsquo\;s Guidance f or Industry. For this reason\, it is important to have clarity and underst anding of how to apply this regulation prior to the initiation of a new pr oduct stability testing program which includes the protocol design\, testi ng\, storage\, data management\, trending and expiration dating extrapolat ions and expectations for products in a new or existing IND or NDA applica tion process.
\n \;\n\nThe Seminar will benefit people within the pharmaceutical\, biote chnology or medical device industries that currently have a stability test ing program but are not savvy about maximizing the use of their data for e xtending their product&rsquo\;s expiration dating. The employees who will benefit most include:
\n\n