ComplianceOnline Announces Interactive Workshop on Design Control for Medical Devices
ComplianceOnline, the leading GRC advisory network, and well known regulatory affairs expert Dr. David Lim, will conduct a day long, interactive workshop on design control for medical devices, including in vitro diagnostic devices.
Online PR News – 08-August-2012 – Palo Alto, California – Palo Alto, CA, USA – August 3, 2012 – ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced an interactive workshop on Design Control for Medical Devices Including In Vitro Diagnostic Devices. The day long workshop led by regulatory affairs expert Dr. David Lim will be held on October 31, 2012 in San Francisco, CA.
This workshop is intended to provide guidance on interpreting, understanding, establishing and maintaining design control for all classes of medical devices including IVDs. The course has been pre-approved by RAPS and participants will be eligible to receive up to 6 RAC credits toward their certification on completion.
For more information or to register for the seminar, please click here.
Seminar instructor Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia. 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. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.
During this interactive seminar, Dr. Lim will provide insight into defining, documenting and implementing design control procedures for medical devices including in vitro diagnostic devices. Design control is necessary in medical device manufacturing as it helps significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of unnecessary time, efforts and investment. Workshop participants will learn about federal regulations governing the medical device industry, design and development planning, design input and output, design reviews, design verification and validation, design evaluation vs specifications, software validation, labeling verification, design transfer, design changes, and design history file.
This seminar will be valuable for anyone in the FDA-regulated industry, including, but not limited to, all classes of medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This workshop is a must for those directly or indirectly involved in research and development, quality, clinical and regulatory affairs handling documentation for 510(k)s and PMAs. In addition, this workshop will also be very beneficial to those preparing for and handling conformity assessment applications for CE marking purposes.
Date: Wednesday October 31, 2012, 9 AM to 4 PM PDT
Location: San Francisco, CA
Registration Cost: $549 per registration
Early bird discounts: For discounts on early registrations, please click here.
Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to email@example.com
For more information on ComplianceOnline or to browse through our trainings, please visit our website.
A Reuben Bernard
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