COURSE "MEDICAL DEVICE DESIGN CONTROL" HAS BEEN PR 2013 - Medical Device Design Control - Webinar By GlobalCompliancePanel

Website http://bit.ly/TlX62T | Edit Freely

Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Helth

Deadline: January 24, 2013 | Date: January 24, 2013

Venue/Country: California, U.S.A

Updated: 2013-01-18 15:53:35 (GMT+9)

Call For Papers - CFP

Understanding, interpreting, and implementing design control requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

In this presentation, you will get familiar with regulatory and quality requirements of design control concerning medical devices, active implantable medical devices and IVDs.

Why Should You Attend: Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs.

Areas Covered in the Session:

Federal Statutes and Regulations Governing Medical Devices in the US

Introduction and Definitions

Design and Development Planning

Design Input

Design Output

Design Review

Design Verification And Validation including Software Validation

Design Transfer

Design Changes

Design History File (DHF)

Device History Record (DHR) and Device Master Record (DMR)

Who Will Benefit:

R&D Scientists, Engineers, Managers, and Directors

Regulatory Affairs

Quality Professionals

Product Development Professionals

CROs

Consultants

Senior Management

Contractors and Subcontractors

Anyone interested in design control

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.

GlobalCompliancePanel

Price: $225.00

Phone: 800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

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