Webinar On Medical Device Recall - FDA Authority, Policy

1. ContactUs:416-915-4458 WeEmpower,YouComply! Medical Device Recall - FDA Authority, Policy and Best Practices to Avoid and Manage ProductId MD1125 Medical Devices Category Tuesday, June 17, 2014 at 13:00 Hrs ScheduledOn Duration 60 Minutes Speaker Casper E. Uldriks Toregisterforthiswebinar visit https://compliancetrainings.com/siteengine/Login.aspx Webinar Description: 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

2. 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 SpeakerProfile: 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. Toregistervisithttps://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1125