Risk Based Strategies for Design Control and Software Validation
Wednesday, January 21, 2009
Orlando, FL | The Regal Sun Resort
We are introducing a new series of seminars titled "Design Control and System Validation Compliance: Industry Leaders Share Best Practices". This is a three day seminar on Design Controls, Safety Risk Management and Validation of Non-product Software and Part 11 from the premier medical device and pharmaceutical companies as well as the FDA. Speakers represent the following medical device companies: Abbott Laboratories, Abbott Vascular, bioMerieux, Certified Compliance Solutions, Covidien, Gambro, GE Medical, Genentech, FDA, Gen-Probe, Ethicon Endo-Surgery, and Siemens Medical Solutions.
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Click here for the Full Agenda
Who Should Attend
Registration
| 1 Event | 2 Events * | 3 Events * | ||
| AdvaMed Member | $1095 | $1990 | $2785 | Register Now |
| Non-Member | $1095 | $1990 | $2785 | |
| AdvaMed EGCC Member | $1095 | $1990 | $2785 | |
| Government | $1095 | $1990 | $2785 |
Agenda Overview
View Full AgendaDuring this seminar you'll learn from FDA and industry leaders:
- How Ethicon-Surgery has integrated product innovation into their design processes
- How to implement a risk based design control process based on IEC 62304:2006
- The most common 483 observations for design control and software validation
- How to define quality metrics to tell you when your new products are ready for market launch
- How to streamline your design change process to enhance customer satisfaction and reduce costs
- How to enhance quality through effective requirements analysis
You'll also get guidelines and checklists for code, design description, requirements specification and test review.
Click here for the Full Agenda
Speakers
Dan Olivier, President, Certified Compliance Solutions, Inc.Javad Seyedzadeh, Senior Vice President RA/QA, Gambro
Teresa O'Shea, Ethicon Endo-Surgery, Director Strategy Execution
Brad Blake, Vice President of Instrument Development, Gen-Probe Incorporated
Robert Kanaley, Quality Systems Advisor, Abbott Vascular
Click here for the Full Agenda
General Information
It is the responsibility of the registrant to verify their company’s active membership status prior to registering. You may check if your company is an active member visiting http://www.advamed.org/MemberPortal/Membership/member_company_listing.htm. There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company. Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.
To receive discounts for registering 3 or more please fax your registration to the attention of Katia Kunze at 202-783-8750. Discounts will not be given retroactively.
For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen. For information regarding Registration issues, please contact Katia Kunze.
Please be advised that any registrations received after 5 pm on Wednesday January 7th will not appear on the participants roster. It is MTLI policy not to release revised participants rosters after the seminar.
CANCELLATION & REFUND POLICY
Location Information
The Regal Sun Resort1850 Hotel Plaza Blvd
Lake Buena Vista, FL 32830
407-827-6529
A limited block of sleeping rooms have been arranged at the Regal Sun Resort for attendees to these Seminars, for a reduced rate of $139/lake view or $159/tower/city view. In order to receive the discounted rate, you must ask for the Advance Medical Technology Association room block. To make toll free reservations please contact 1-800-624-4109. Please make your reservations early as this rate is effective until January 9, 2008. Rates and room availability are subject to change after the January 9th date.