Webinar on Medical Device Tracking 2011

March 14, 2011 - PRLog -- The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA in section 519(e) required mandatory tracking even if FDA did not issue an order.

Section 519(e), as revised by FDAMA, states the agency may require tracking for a class II or class III devices: (A) the failure of which would be reasonably likely to have serious adverse health consequences; or (B) which is intended to be implanted in the human body for more than one year; or (C) which is a life sustaining or life supporting device used outside a device user facility.

This medical device tracking webinar training will address the latest FDA guidance requirements and expectations and expound on why and what are the information, the tracking methods must provide about the location of a tracked device. We will also discuss the role and responsibilities and the impact with user facilities and patient issues.

Areas Covered in the Seminar:

- Review the key provisions in the updated FDA guidance on medical device tracking.
- Understand the regulatory expectations for device tracking.
- Identify new terms and criteria.
- Understand the statutory criteria and what changed.
- who are required to track various implantable devices - FDA has issued orders to manufacturers
- What are the additional guidance factors to be considered when determining whether a tracking order should be issued
- Understand why tracking methods are subject to FDA inspection
- When does tracking end?
- Identify what information to report and your responsibilities
- Understand the impact with user facilities and patient issues

Who Will Benefit:

This webinar will provide an overview and guidance to device manufacturers involved in medical device tracking activities. Employees who will benefit include:

- All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the Medical Device Tracking process and FDA’s latest expectations
- Regulatory Affairs
- Clinical Affairs
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Consultants

Instructor Profile:

David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the life sciences and FDA regulated industry, has an extensive regulatory background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory landscape. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses EU regulatory requirements regarding MDD and CE Mark. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, Notified Bodies, AR’s and demonstrates credible experience to maximize business performance in the devices arena.

For more details:
http://www.complianceonline.com/ecommerce/control/trainin...

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