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Managing GLP Studies in Non-GLP Facilities - Webinar By ComplianceOnline
Friday, July 6, 2012 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
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?
When & Where
At ComplianceOnline, we are focused on :
- 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.