Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) in Drug Development: Fundamentals, Regulatory Trends and Best Practices

This workshop will be conducted in two sessions:

I. Good Laboratory Practices (GLPs): Fundamentals, Regulatory Trends and Best Practices

This section includes a discussion on the history of Good Laboratory Practices (GLP) regulations, the importance of the regulations, key definitions, areas covered by the GLPs, a review of the regulations, examples of misconduct and, potential FDA actions. After completing this workshop, participants should be able to understand the origin, purpose, and expectations of the GLP regulations.

List of Topics

• General Provisions
• Organization and Personnel
• Facilities and Equipment
• Testing Facilities Operations
• Test and Control Articles
• Records and Reports
• Disqualification
• FDA Actions and Misconduct

II. Good Manufacturing Practices (GMPs) from R&D through Commercialization: Fundamentals, Regulatory Trends and Best Practices

This section includes a discussion on the history of Good Manufacturing Practices (GMP) regulations from R&D through Commercialization, key definitions, areas covered by the GMPs, a review of the regulations, examples of misconduct and, potential FDA actions. After completing this workshop, participants should be able to understand the origin, purpose, and expectations of the GMP regulations.

List of Topics

• Basis of GMPs
• CGMPs on a continuum
• Current FDA Expectations and Focus
• Oversight of CMOs

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