Event

Lot Disposition in a Clinical and Commercial Setting – Meeting US, Canada and EU Regulatory Expectations

March 6, 2012 iCal

Time: 12:00-2:00pm
Location: LIVE, INTERACTIVE TRAINING WEBINAR; IN YOUR OFFICE

Disposition and release of materials from plants, whether they be your own facilities or those of your contract manufacturers, is a key step in the process of manufacture of product to fuel your clinical trial or your commercial sales and marketing groups.

This live training webinar will provide valuable information on the requirements for lot disposition as defined by the regulations in USA, Canada and the EU. This will enable you to see how successful companies can translate these requirements into workable processes that are compliant with the regulations and yet efficient from a business perspective. Elements of risk management will be discussed as they pertain to development and execution of a system for lot disposition for clinical as well as commercial products for products manufactured within your own plants as well as those manufactured in your contract manufacturer's facilities. The webinar will present some metrics that can be put into place to measure your performance versus expectations which will set you on the road to continuous improvement. With this information you will be able to benchmark against some successful companies. You will also see how companies run foul of the agencies resulting in warning letters and how from this information you will be able to assure that you do not suffer the same fate.

Learning Benefits:

-The requirements for lot disposition.

-What regulations govern lot disposition.

-How to assemble and review the raw data and information and make rational decisions.

-How to incorporate risk management into the disposition process so you can focus your resources in the most vulnerable areas.

-The different challenges and how to manage them with clinical trial materials versus commercial products.

-What the agencies expect from you to convince them you are in compliance and in control.

-How to manage contract manufacturers and the release of materials.

-Where companies go wrong and get into regulatory hot water and how to avoid it yourself.

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