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FDA Recalls - Before You Start, and After You Finish (CSE)

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Mebane, NC 27302

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FDA Recalls - Before You Start, and After You Finish

About

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 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.

AGENDA


Day 01(8:30 AM - 4:30 PM)
Day 1 - Morning
08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
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 02(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

SPEAKER

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

Casper (Cap) Uldriks
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorship

NO REFUNDS ALLOWED ON REGISTRATIONS
Prices may go up any time. Service fees included in pricing.
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Date and Time

Location

Venue will be informed to the Registered Participants

Mebane, NC 27302

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Refund Policy

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