Objectives

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

  • Describe current issues in the FDA’s Office of Regulatory Affairs, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research
  • Identify how to control human error on the manufacturing floor
  • Learn about the challenges posed by clients and international regulatory agencies in contract manufacturing
  • Adopt recommendations to improve data integrity monitoring programs
  • Explore U.S., European, and Canadian trends and views in GMP manufacturing
  • Understand recent trends in recent domestic and international GMP violations
  • Outline the processes used in complaint handling
  • Understand how compounding pharmacies are impacting the regulatory sciences
  • Evaluate how to implement ingredient supplier qualifications

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