Objectives

At the conclusion of this conference, attending participants should be able to:

  • Describe current issues in the FDA’s Office of Regulatory Affairs, Office of Manufacturing Quality, Office of the Ombudsman and  Office of Pharmaceutical Quality
  • Identify how quality systems can lead to innovation in drug development
  • Learn how to maintain quality when using virtual manufacturing
  • Adopt quality systems to monitor data integrity
  • Explore U.S., European, Asian, Latin American and Canadian trends and views in GMP manufacturing
  • Describe trends in recent GMP violations
  • Outline the processes used in foreign inspections and trends from these inspections
  • Understand how combination products are impacting the regulatory sciences
  • Explore continuous manufacturing and other emerging manufacturing technologies
  • Evaluate how social media is impacting complaint handling

 

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