Systems Engineering: The Bridge Between the Aerospace and Medical Industries
Attend this day of stimulating thought and discussion centered around the questions: How is classical Systems Engineering applied to the aerospace and medical industries (e.g., design requirements, verification, validation). Do these industries have similar or different approaches to SE and what can they learn from each other. The medical industry and FDA have recently come under fire for allowing unsafe products on the market – can SE help improve the safety, efficacy and quality of medical products? All are welcome.
Keynote Speaker: Daniel P. Olivier
Dan is an acknowledged quality systems expert that has provided consulting services for over 200 medical device and pharmaceutical companies in design controls, software validation, and safety risk management practices. He has been contracted by FDA to train investigators and to provide inputs to software validation guidelines. Speaker at over 50 American Society for Quality (ASQ) and other professional conferences. Author and presenter of over 50 seminars on Computer System Validation, Safety Risk Management, and Part 11 requirements to meet FDA and ISO Guidelines. RAB certified ISO 13485:2003 lead auditor with experience from over 100 audits of medical device and pharmaceutical companies. Reviewer for International Organization for Standardization (ISO) WG10 defining software process assessment standards. Ten years experience as a software engineering instructor at undergraduate and graduate levels including UCSD Extension program and National University.
LUNCH: Buffet and soft drinks will be provided. Please state vegetarian preferences with your registration.
0800 – 0900 Registration, Coffee & Donuts
0900 – 0915 Introductions & Welcome
0915 – 1000 Keynote Address by Daniel P. Olivier [Presentation]
1000 – 1045 Technical Presentation: “A Brief History of Systems Engineering” by Mark Halverson [Presentation]
1045 – 1100 Break
1100 – 1145 Technical Presentation: “Intended Use Validation of Rational DOORS for Use in a FDA Regulated Environment” by Deric Merino
1145 – 1200 Vendor Introductions
1200 – 1315 Lunch & Vendor Exhibits
1315 – 1345 Technical Presentation: “Enterprise Architecture of Emergent Complex Adaptive Systems” by Claudia Rose
1345 – 1415 Technical Presentation: “Information Modeling for Systems Integration” by Kim Idol, Claudia Rose, and Alan Brenner
1415 – 1445 Technical Presentation: “Regulatory Affairs Arguments” by Alan Brenner
1445 – 1545 Panel Discussion
1545 – 1600 Wrap-Up
Save! — Early registration can be completed online until November 1 (payment through PayPal only.) $20 of any non-member fee can be applied toward INCOSE membership for those who join at this conference. Speakers and Panelists admitted free. On-site registration by cash or check only, no credit cards please! Admission fee includes coffee and donuts, buffet lunch and soft drinks.
|Registration Fees||Early Online Registration by 11/1/2011||Online Registration after 11/1/2011||On-Site Registration (cash or check only)|
National University La Jolla 11355 N. Torrey Pines Road San Diego, CA 92037