FDA Recalls - Before You Start, and After You Finish

FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that, "You don't get it."

Your compliance competency becomes a regulatory issue for the FDA if your recall is deemed ineffective. The seminar will cover critical performance targets for conducting an effective recall. You will learn how missteps in the recall process become an expensive problem in terms of money and a sloppy corporate image.

Learning Objectives:

• Understand FDA's recall authority and policy
• Learn how to manage recalls under FDA oversight
• Learn how to interact with FDA
• See how to develop health risk determinations
• Learn critical recall strategy components
• Manage possible FDA enforcement actions

Who will Benefit:

• Recall managers
• Quality assurance managers
• Regulatory affairs directors
• Risk and product liability managers
• Manufacturers’ sales and marketing managers
• Own label distributors

  Companies and departments:

  • Manufacturers
  • Own Label Distributors
  • Importers
  • Healthcare institutions
  • Nursing homes
  • Medical practice groups