Live eLearning - PDA 459.2 Biopharmaceutical Manufacturing under Regulatory Compliance: Process Strategies, CGMP Considerations

Biotechnology is the use of biological processes and components to provide useful products, services and tools for a variety of applications. Biological and drug products under the regulatory review and approval by the United States Food and Drug Administration are required to be manufactured in compliance with current Good Manufacturing Practices regulations (CGMPs). Sponsor organizations are expected to use appropriately designed facilities and to have in place phase-appropriate Quality Systems for clinical trial product manufacturing as well as for commercial product manufacturing.

This training course is designed to expose participants to a variety of topics including biologics product modalities, biopharmaceutical process development and manufacturing, current requirements for CGMP manufacturing of biopharmaceutical products and how to plan for CGMP implementation in your facility, and bulk plant design from a process/product perspective. The training course format uses a combination of lecture and case studies discussion.

1. Explain the biopharmaceutical product and process development steps
2. Describe and understand the key steps in typical biopharmaceutical manufacturing processes
3. Understand CGMP requirements
4. Develop a plan to implement CGMPs in your operations
5. Identify the issues involved with designing a manufacturing facility for biological products under FDA CGMP compliance