Conference Description:

According to the FDA, CFR part 58, good laboratory practices (GLPs) are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

Areas Covered in the Session :

>. Understanding good laboratory practices (GLP)
-GLP as an FDA regulation
-Definition of GLPs
-History of GLPs
-Why were GLPs created?
-Objectives of GLPs
-Mission of GLPs
>.The objective of GLPs and how are they associated with GMPs and SOPs
>.Statistical procedures for data evaluation

Who Should Attend:

>. Regulatory Affairs Departments
>. Quality Assurance Departments
>. Quality Control Departments
>. Research and Development Departments
>. Manufacturing Departments
>. Operations Departments
>. Production Departments
>. Documentation Departments
>. Validation Teams