Validation of Non-product Software: Assuring Compliance and Improving Quality
Thursday, January 22, 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..JPG)
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 to use TIR 36 to define validation practices for non-product software
- FDA's compliance observations regarding software validation and Part 11
- How industry leaders are using ITIL to tailor software validation processes
- How to validate ERP systems using a risk based strategy
- What pitfalls to avoid for the rollout of global IT systems
- Screening, analysis, and prevention of software defects
You'll also get custom checklists for Part11 and TIR 36 as well as a sample software validation procedure.
Click here for the Full Agenda
Speakers
Dan Olivier, President, Certified Compliance Solutions, Inc.Veronica Lim, Senior Computer Systems Governance, Genentech
Regina Rohe, Director of Information Quality and Validation, North America, bioMerieux
Vinnie Chopra, Senior Manager, Process, Siemens Medical Solutions
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.