GCP-GLP-GMP : Comparison and Understanding of FDA's 3 Major Regulations

Overview:

For manufacturers for drugs, biologics, biosimilars, generics, and medical devices, firms are subject to various statutory and regulatory requirements under FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). To provide safe and effective medical products, it is important for the FDA-regulated industry to accurately understand and apply the applicable regulations and requirements under GLP, GCP and GMP.

Why you should Attend:

This webinar is intended to help FDA-regulated industry and professionals get better aware of and familiar with the GLP, GCP and cGMP requirements from practical, actionable perspectives. This webinar will help firms implement and achieve compliance with the FDA regulations with improved awareness.

Areas Covered in the Session:

• Laws and Regulations
• FDA Guidance and Definitions
• Good Laboratory Practice Regulations and Requirements
• Regulations and Requirements for Good Clinical Practice
• Regulations for Current Good Manufacturing Practice for Food, Drugs, Biologics and Medical Devices
• Common Mistakes and How to Avoid Them
• FDA Enforcement Cases
• Best Practices: Dos and Don'ts

Who Will Benefit:

• CEO's
• VPs
• Compliance Officers
• Attorneys
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• R&D
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the FDA Drug Review and Approval Processes