Fundamentals of Good Manufacturing Practices for Biopharmaceuticals

Fundamentals of Good Manufacturing Practices for Biopharmaceuticals is a workshop dedicated to the current Good Manufacturing Practices (cGMPs) for producing safe and effective Biopharmaceuticals.

Topics

• Regulatory Authorities for Drugs, Biologics, and Medical Devices
• Biopharmaceutical Production Methods and Regulatory Considerations
• CGMPs for Biopharmaceuticals
• Biopharmaceutical Regulations for Drugs, Biologics, and Medical Devices
• Emerging Trends and Regulatory Initiatives for Biopharmaceuticals
• ICH Quality Guidelines, Standards and Definitions
• Product Lifecycle and Quality Culture
• Drug Development and Regulatory Approval Process
• Supply Chain and Supplier Management
• Risk Management and Regulatory Enforcement