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EVENT DATE
Sep 2017
M T W T F S S
04050607080910
EXPO DATE
Sep 2017
M T W T F S S
04050607080910

Venue

Venue TBD
San Diego , CA 92101
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Designing and Sustaining New and Existing Product Stability Testing Program

Venue TBD
B2B 30

EVENT DESCRIPTION

 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 Management
  • Senior Management
  • Manufacturing Associates and Management
  • Shipping and Distribution Personnel
  • Stability Testing Department Personnel and Management
  • Regulatory Affairs
  • Quality Assurance Analyst and Management
  • Process Design Personnel and Management
  • Drug Packaging Personnel and Management

 

Note: Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-drug-stability-testing-program-seminar-training-80320SEM-prdsm?channel=eventsinamerica

There may be many networking opportunities at the Designing and Sustaining New and Existing Product Stability Testing Program. Find out more in the event details below.

EVENT CONTACTS

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EVENT DETAILS

Primary Industry:
Sciences
Other Industries:
Business, Sciences
Audience:
Quality Control Analyst and Management
Senior Management
Manufacturing Associates and Management
Shipping and Distribution Personnel
Stability Testing Department Personnel and Management
Notes:
Show Owner:
ComplianceOnline
Sponsorship:

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ComplianceOnline

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