Managing GLP Studies in Non-GLP Facilities - Webinar By ComplianceOnline

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.

This webinar begins by clarifying what constitutes a GLP study. It explains where development work ends and GLP regulations begin. It describes the important transition between new drug development, which is not governed by regulations, and safety testing, which is in the scope of GLP. The presenter gives tips on good recordkeeping for the synthesis methods used in new drug development. The discussion also describes the risks of not understanding the GLP/non-GLP distinction. It describes the challenges of running regulated studies in the same lab as basic research. Special examples in equipment use, reagents, reference standards, and storage units are discussed.

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?