Webinar On Medical Device Recall - FDA Authority, Policy and Best Practices to Avoid and Manage

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Medical Device Recall - FDA Authority, Policy and
Best Practices to Avoid and Manage
Product Id
MD1125
Category
Medical Devices
Scheduled On
Tuesday, June 17, 2014 at 1300 Hrs
Duration
60 Minutes
Speaker
Casper E. Uldriks
To register for this webinar visit
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Webinar Description

Medical device firms need to be aware of the
benefits of compliance as well as the dangers of
inadequate complaint handling. FDAs recall
authority and program launches you into a project
of crisis management. You will learn how to
establish a roadmap for conducting recalls. The
recall management knowledge you gain will sharpen
how you determine the health and legal risks
associated with your recall and what you can do
to avoid future recalls. 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 firms 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.

Areas Covered in the Session

• Understand FDAs 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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Who will benefit

• Complaint Handling Personnel
• Clinical Affairs Teams
• Product and Development Teams
• Site Managers and consultants
• Contract manufacturing organization
• Contract research organization
• Senior and executive management
• Contractors and subcontractors

Speaker Profile

Mr. Uldriks held a number of positions at FDA,
such as an investigator in FDA's New England
office, in the Office of the Commissioner in
Legislative Affairs and in the Center for Devices
and Radiological Health (CDRH), where he served
as CDRH's Associate Director for Regulatory
Guidance and Government Affairs. He helped to
guide CDRH to develop and implement various
medical device related amendments to the Food,
Drug, and Cosmetic Act, regulations and guidance
documents. For years he has trained FDA staff on
medical law and has been a featured speaker at
many professional conferences involving FDA's
medical device program. He is of counsel at
Olsson Frank Weeda (OFWLAW) in Washington, DC and
licensed to practice in Massachusetts and the
District of Columbia.
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