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FDA Recalls - Before You Start, and After You Finish

Location: District of Columbia, USA
From: 2019/10/10 8:30
To: 2019/10/11 16:30
Posted by: ComplianceOnline
Tickets - Prices from: $0.00

FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for javascript:nicTemp();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."

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
Topic Background:

The products regulated by the FDA can cause serious adverse health consequences or death. The FDA's recall program is designed to make sure firms' recalls can mitigate such problems, even when the adverse consequence seems remote. The FDA's recall program has remained relatively the same over several years. How the FDA and industry manage recalls and learn from their mistakes continues to evolve. In some ways recalls have become more efficient through the benefit of technology. In other ways the reason for recalls remains substantially the same. The FDA's recall procedures and regulatory management of any risk to health are still sufficient to determine whether a recall is effective and whether manufacturers learn from their mistakes.

For Registration :

https://www.complianceonline.com/fda-recall-program-training-workshop-seminar-training-80331SEM-prdsm?channel=referral_indiaevents



FDA Recalls - Before You Start, and After You Finish


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