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Event Details
This 90-minute webinar will help you understand when a new product being developed begins to fall under the umbrella of a regulated study, teach you the basic principles of GLP study to better separate regulated activities from basic research, provide practical tips on how to keep GLP-related materials separate from non-GLP materials, and manage equipment designated for GLP use.
Why Should You Attend:
An increasing number of companies and universities are running GLP studies or study phases in facilities that have never before been part of a regulated environment. Performing a GLP study in a non-GLP facility presents special challenges. If these challenges are not addressed properly, parts of a study might be non-compliant, increasing the risk of study rejection. This presentation describes the obvious challenges in running GLP studies in labs where non-GLP and other unrelated experimentation occurs. It offers tips on how to manage and separate GLP activities from non-GLP activities.
Areas Covered in the Seminar:
- What constitutes a GLP study?
- What are the biggest risks in mixing GLP and non-GLP work in the same facility?
- How to separate GLP from non-GLP reagents
- How to keep test articles and reference standards away from non-GLP
- How to divide labs into GLP and non-GLP zones
- How to identify testing facility management
- How to train graduate students, interns, etc., in GLP
- What goes into the compliance statement when non-GLP activities are part of a GLP study?
For Registration:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702342?channel=Eventbrite
When & Where
Online Webinar
2600 E. Bayshore Road
Palo Alto,
CA 94303
Friday, July 6, 2012 from 10:00 AM to 11:30 AM (PDT)
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