Medical Device Design Control - Webinar By GlobalCompliancePanel

Event Details

Time: May 8, 2013 from 10am to 11am
Location: Online Training
Street: 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
City/Town: Fremont
Website or Map: http://bit.ly/YELPxy
Phone: 8004479407
Event Type: webinar, healthcare, medical, device, pharmaceutical, clinical
Organized By: GlobalCompliancePanel
Latest Activity: Apr 29, 2013

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Event Description

Overview: 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.

This webinar will greatly help medical device industry and relevant professionals establish and maintain adequate design control procedures.

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.

Price: $225.00

GlobalCompliancePanel

NetZealous LLC,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

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