Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. 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 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 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.
Areas Covered in the Session :
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
Who Will Benefit:
Quality & Regulatory Professionals
Manufacturing & Design Engineers
Marketing Product Managers
Documentation Personnel
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
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
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.
For more information Contact
Compliance Trainings
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