Enhancing Safety Risk Management
Tuesday, January 20, 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:
- Causes of safety related recalls and how they could have been prevented
- What to include in your risk analyses, risk evaluation, risk control, and post production information
- Lessons from safety recalls and how they can be prevented
- How to determine acceptable levels of safety risk
- What safety risk management techniques you should use (FMEA, FTA, HACCP and HAZOP)
- How Safety risk management can imporve your product design
You'll also get a checklist with over 130 common safety risk mitigation techniques commonly used to reduce risk.
Click here for the Full Agenda
Speakers
Tracey Holevas, Quality Assurance Risk Manager, GE Healthcare
Dan Olivier, President, Certified Compliance Solutions, Inc.
Todd Hansell, Manager Systems Design Quality Assurance, Covidien
Ron Gerner, Manager Software Quality Assurance, Abbott Laboratories
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.