THIS WEBINAR IS INTENDED TO DEMONSTRATE HOW TO DEF 2012 - Medical Device Reporting (MDR) - Webinar By GlobalCompliancePanel

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Category Online Training,FDA Regulations,Medical Device Reporting (MDR),document, implement,

Deadline: October 25, 2012 | Date: October 25, 2012

Venue/Country: Wilmington, U.S.A

Updated: 2012-09-27 19:49:01 (GMT+9)

Call For Papers - CFP

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. It is critical to understand how to define, document, implement, and maintain the procedures for MDR.

This webinar will greatly help device industry and relevant professionals understand how to define, document, implement, and maintain the procedures for MDR.

Why Should You Attend: Device manufacturers are required to establish and maintain a medical device adverse event reporting system, commonly known as Medical Device Reporting. This webinar will demonstrate how to define, document, implement, and maintain the necessary procedures for medical device reporting.

Areas Covered in the Session:

Relevant Statutes And FDA Regulations

Definitions

Regulatory Requirements For Medical Device Reporting (MDR)

Requirements To Be Addressed In the Procedures

Review of the MDR Form

How To Report Medical Device Adverse Events

Reporting Requirements For The User Facilities, Manufacturers, And Importers

Enforcements: Numerous Case Studies

Who Will Benefit:

Complaint Handling and Risk Management Managers and Directors

Compliance Officers and Legal Counsel

Regulatory Affairs

Clinical Affairs

Quality Assurance, Quality Control, and Quality Systems

Research and Development

Product and Development

Marketing

Site Managers, and Consultants

Contract Manufacturing Organization

Contract Research Organization

Senior and Executive Management

Contractors and Subcontractors.

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.

Webinar By GlobalCompliancePanel

Price List:

Live : $245.00

Corporate live : $495.00

Recorded : $295.00

Phone: 800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

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