Fundamentals of Good Manufacturing Practices for Biopharmaceuticals is a workshop dedicated to the current Good Manufacturing Practices (cGMPs) for producing safe and effective Biopharmaceuticals.
Fundamentals of Good Manufacturing Practices for Biopharmaceuticals covers topics such as:
- 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
