At the conclusion of the conference, attending participants should be able to:
- Describe current issues in the FDA’s Office of Regulatory Affairs and the Center for Drug Evaluation and Research
- Identify approaches to risk management for pharmaceutical manufacturing systems
- Learn about the challenges in manufacturing and quality with advanced breakthrough therapeutics
- Adopt recommendations to improve data integrity monitoring programs
- Explore U.S., European, and Canadian trends and views in GMP manufacturing
- Understand CDER’s knowledge-aided assessment and structured application (KASA) program
- Outline the processes used in complaint handling
- Understand how artificial intelligence and cybersecurity will impact quality systems and manufacturing
- Evaluate how to implement supplier qualifications
- Discover best practices in communicating with health authorities
In addition, attending participants will have the opportunity to:
- Interact with FDA and global regulators and network with your peers on GMP issues
- Receive valuable information and ideas that will be beneficial towards improving their companies