FDA Recall Authority and Program Launches: Before You Start, and After You Finish – Washington, DC, United States – October 10-11, 2019

DUBLIN, Aug. 30, 2019 /PRNewswire/ -- The "FDA Recalls - Before You Start, and After You Finish" conference has been added to ResearchAndMarkets.com's offering.

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.

You will take away practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action, and in some cases a legal action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the negative impact of a recall with the use of proper planning.

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 Should Attend:

• 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

Agenda:

Day 1

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

Day 1 - Morning

FDA's Regulatory Authority

Recall Regulations

• Voluntary recall: 21 Code of Federal Regulations (C.F.R.) Part 7
• Mandatory recall actions
• 21 C.F.R. Part 810
• 21 C.F.R. Part 806

Recall Classification

• Violation of the law

Break (10:30 a.m. - 10:45 a.m.)

• Risk to Health
• Precedents
• Exemptions
• Stock Recovery
• Product Withdrawal
• Product Improvement

Lunch (12:00 p.m. to 1:00 p.m.)

Recalls and risk to health

Risk to health categories

• Death
• Serious injury / serious illness
• Non-reversible / reversible
• May cause, if it were to recur
• Remote possibility

Break (2:30 p.m. - 2:45 p.m.)

Health Hazard Evaluation for Recall Classification

• FDA's internal evaluation
• Vulnerable subpopulations
• Scoring
• Participants
• Industry HHE equivalent
• FDA's recall database

Day 2

FDA's Recall Procedures

• Understanding FDA's program and implementation
• FDA's agency-wide recall procedures
• The FDA's investigator's job
• Preparing a recall strategy

Break (10:30 a.m. - 10:45 a.m.)

Preparing for FDA oversight

• Recall notification to FDA's District Office
• Recall notification to the public

Lunch (12:00 p.m. to 1:00 p.m.)

• Root cause identification
• Correction and Prevent Action (CAPA)

Break (2:30 p.m. - 2:45 p.m.)

• FDA inspectional follow up
• Enforcement: FDA administrative and legal remedies
• End

For more information about this conference visit https://www.researchandmarkets.com/r/juqg16

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Research and Markets Laura Wood, Senior Manager
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