FDA Recalls - Before You Start, and After You Finish

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Category FDA Compliance;

Deadline: May 18, 2016 | Date: May 18, 2016-May 19, 2016

Venue/Country: Chicago, U.S.A

Updated: 2016-04-13 21:50:06 (GMT+9)

Call For Papers - CFP

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

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.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

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