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ComplianceOnline, DoubleTree Bloomington - Minneapolis South, 7800 Normandale Boulevard,
2013-03-21
Course Description:
You will understand the critical performance targets to accomplish an effective recall and learn how missteps in the recall process become counterproductive and expensive. 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 an enforcement action. You will learn that your approach to an enforcement action plays a major role in mitigating the firm’s business consequences due to a recall. 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 likelihood or significance of a recall with proper planning.
Learn practical tips from your course instructor Mr. Casper (Cap) Uldriks who brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations.
Learning Objectives:
- Understand FDA’s recall authority and policy
- Learn the mandatory requirements for device recalls
- Learn how to interact with FDA
- See how to develop health risk determinations
- Learn critical recall strategy components
- Identify options for FDA enforcement action
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Organized by:
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Complianceonline |
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Invited Speakers:
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Casper (Cap) Uldriks
An ex- FDA expert and former Associate Center Director of CDRHCasper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations. Starting in 1995, he trained the FDA’s investigators on the FDA’s legal authority and CDRH’s regulatory requirements and procedures. He continues to teach the FDA’s employees to this day. He is recognized and sought out as an exceptional and energetic speaker. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed.
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Deadline for Abstracts:
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2013-03-20
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Registration:
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http://www.complianceonline.com/ecommerce/control/seminar/~product_id=80084SEM?channel=Hummolgen
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E-mail:
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referral@complianceonline.com
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