Short Abstract

This webinar is intended to help you get familiar with the relevant and applicable US regulations, regulatory requirements and guidance necessary for good laboratory practice (GLP) and GLP compliance. This webinar is further intended to provide guidance on GLPs for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products including, but not limited to, biologics, human drugs, biosimilars and medical devices for human use regulated by the United States Food and Drug Administration (US FDA).

The US FDA regulates scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices including biosimilars. Those who conduct preclinical studies that support or are intended to support applications for research or marketing permits for products (e.g., biologics, drugs, biosimilars and medical devices) are subject to compliance with the relevant and applicable statutes and GLP regulations. Compliance with the GLP regulations is intended to assure the quality and integrity of the safety data filed pursuant to the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) and the Public Health Service Act (PHS Act).

Understanding GLP regulations and requirement and achieving GLP compliance can significantly contribute to expediting the regulatory processes, bringing innovative medical products to the market faster.

This webinar will discuss GLP regulations, requirements and compliance including how to prepare for GLP inspection. At the end of the webinar, you will get familiarized with the applicable FDA GLP regulations, requirements and how to achieve GLP compliance.

The presentation will cover the following areas:

• Overview and review of US FDA GLP regulations and requirements.
• Good laboratory practices: scope, objectives and definitions.
• Organization and personnel: personnel, management, study director and quality assurance unit.
• Facilities and equipment.
• Testing facilities operation: standard operating procedures (SOPs).
• Test and control articles.
• Protocol and conduct of a GLP study.
• Records and reports.
• GLP compliance and inspection.
• Ten (10) case studies for enforcement actions
• Lessons learned