For more information or to register for the workshop, please visit
This interactive 2-day workshop will cover the essential elements of a medical device quality management system involved in creating an effective Risk Management system. Using the GHTF guidance document for a framework, the seminar covers the QMS essentials (ISO 13485 & QSR) that have the most direct impact on Risk Management. These QMS activities include product planning, design and development, supplier management, process validation, customer complaints, internal quality audits, corrective action, preventive action, and post-market surveillance. In addition, the seminar clarifies the requirements for verification and validation. The material compares and contrasts ISO 13485 and FDA QSR requirements.
The speaker, Daniel O'Leary, will also address Risk Management elements of the US, EU, and Canadian regulatory systems. These include risk classification for medical devices, complaint management, and adverse event reporting. In addition, the training discusses the Global Harmonization Task Force (GHTF) guidance document, Implementation of Risk Management Principles and Activities within a Quality Management System.
The event will benefit Quality, Regulatory, Project and Risk Management professionals working in the medical device sector. Those involved in the Production, Design and Manufacturing of Medical Devices will also find this seminar extremely useful.
Conference details (location and price):
Sheraton DFW Airport Hotel
4440 West John Carpenter Freeway
The hotel is 10 minutes away from Dallas Fort Worth International Airport; complimentary shuttle available.
Date: June 13 - 14, 2011, 9 AM to 5 PM Central, on both days.
Registration cost: $1195 only (includes all course materials and lunch for the 2 days).
Early bird registrations:
Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare@
For more information on ComplianceOnline or to browse through our trainings, please visit http://www.complianceonline.com
About the Speaker:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.
He has a Masters Degree in Mathematics;
ComplianceOnline is a Palo Alto-based leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. We have successfully trained over 15000 professionals from 3000 companies to comply with the requirements of regulatory agencies.
Our training programs are designed and delivered by top-rated experts from respective industries. Our trainings are proven, powerful and highly rated by industry practitioners.
Our trainings cater to FDA regulated industries - Biotechnology, Pharmaceuticals, Clinical, Medical Devices, Food, Hospitals & Healthcare - Energy, BFSI, Trade and Logistics, HR and Quality compliance and more.
Please visit http://www.complianceonline.com or call +1-650-620-3937 for more information or to register for our trainings.
Customer Testimonials for Daniel O'Leary's Trainings:
"Dan O’Leary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.” - Quality Manager, Parker Hannifin Corp
"I enjoyed this Webinar very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company." - Compliance Coordinator, Diagnostica Stago, Inc.
"With the simple approach take by Dan, anyone can learn how to complete a successful process validation."
For more information please contact:
A Reuben Bernard
Manager of Program Marketing
2600 E Bayshore Rd
Palo Alto CA USA 94303
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