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FDA Recalls - Before You Start, and After You Finish  

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

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Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


FDA Recalls - Before You Start, and After You Finish: 2-Day In-Person Seminar by Ex-FDA Official

By: Casper (Cap) Uldriks, Former Associate Center Director of FDA's CDRH

Course Description:

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

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.

Course Outline: Day One (8:30 AM - 4:30 PM)

8:30 AM - 9:00 AM: Registration Process

9:00 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.)

Day 1 / Afternoon

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 Two (8:30 AM - 4.30 PM)

Day 2 / Morning

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.)

Day 2 / Afternoon

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

Seminar Summary:

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. (see full course description)

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