Managing GLP Studies in Non-GLP Facilities

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.

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?