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