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Q1 Productions prides itself as leading provider of educational conferences, workshops, and webinar programs for the Life Science Industry. In August, Q1 will be hosting a series of webinars specific to executive teams from medical device companies. The webinars will be held on August 11th and August 19th. Each session will be presented by Casper E. Uldriks, JD, MDiv, Regulatory Health Scientist at the Center for Devices and Radiological Health of the FDA. Mr. Uldriks is recognized as the FDA's expert in the interpretation and application of several statutory provisions.
About the Webinars
FDA Medical Device Reporting Regulations - August 11 at 2PM – 3:30PM EDT
The Medical Device Reporting (MDR) regulation is an important function of FDA’s post-market device program and works in a dynamic function with other device regulations. This webinar will cover the following post-market regulatory issues:
• Key sections of the MDR regulation;
• Policy behind the MDR regulation;
• Practical implementation considerations;
• Enforcement;
• How the MDR regulation works in conjunction with other post-market regulations for devices.
FDA Reports of Corrections and Removals for Medical Devices - August 19 at 2PM – 3:30PM EDT
The Reports of Corrections and Removals (C&R) regulation is concerned about what firms do about problems identified through Medical Device Report (MDR) regulation and the Quality System Regulation (QSR). These regulations create a foundation for risk management that is central to FDA’s regulatory concerns, particularly for C&R. The seminar will include the following post-market regulatory issues:
• Purpose of the regulation;
• Parallel concepts with MDR and voluntary recalls concerning risk to health;
• Key sections of the C&R regulation;
• Enforcement;
• C&R as part of a interdependent regulatory system for devices.
These sessions summarize the same information that has been used to train FDA investigators.
Each webinar will consist of a 60 minute presentation and a 30 minutes question and answer portion. Registrants will have the benefit of an in-house training session with a seasoned FDA officer. In addition, participants are encouraged to submit questions to speaker prior to the date of each webinar to ensure their concerns are addressed directly. The webinar platform allows for multiple users from various sites to access the information and share common challenges.
When: August 11, 2009 and August 19, 2009 2:00 EDT – 3:30 EDT
Cost
To register one participant the cost is $395 per webinar
For unlimited participants the cost is $495 per webinar
*Sign up for both webinars and receive unlimited access for only $395 per webinar
About Q1 Productions
Q1 Productions (q1productions.com) has over 25 years of combined event management experience, with previous roles in international Sales Management, Productions and Operations. Focusing on new or pending legislative issues, enhanced business processes or technologies that will drive efficiency and customer service, our conference programs provide solutions to the urgent needs of our attendees.
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