Description

For manufacturers of 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. 

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

Areas Covered in the session:

• Laws and Regulations
• Definitions
• Regulations and Requirements for Good Laboratory Practice
• Regulations and Requirements for Good Clinical Practice
• Regulations for Current Good Manufacturing Practice for Food, Drugs, Biologics and Medical Devices
• FDA Guidance and Standards
• FDA Enforcement Cases
• Best Practices: Dos and Don’ts

Who Will Benefit:

• CEOs
• 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.