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1st Edition  Conference

FDA Recalls - Before You Start, and After You Finish


"Develop health risk determinations"
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."

Highlights

  • FDA’s Regulatory Authority,Voluntary recall: 21 Code of Federal Regulations (C.F.R.) Part 7
  • Understanding FDA’s program and implementation,Enforcement: FDA administrative and legal remedies
  • Health Hazard Evaluation for Recall Classification,FDA’s agency-wide recall procedures
  • Understand FDA's recall authority and policy,Learn how to manage recalls under FDA oversight
  • See how to develop health risk determinations,Manage possible FDA enforcement actions

Timings

8:30 AM - 4:30 PM (Oct 10) (General)
8:30 AM - 4:30 PM (Oct 11) (General)

Entry Fees

Paid Ticket Starts from 1499 USD View Details

Participants

20 Delegates
5 Exhibitors Estimated Count

Category & Type

Conference
Education & Training
Food & Beverages

Editions

10-11 Oct 2019 Interested


Frequency Bi-annual

Official Links

Website Contacts


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ComplianceOnline USA

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1499 USDAttendee Seminar One Registration
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Venue Map & Directions

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Venue to be announced

Washington DC, USA

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