Workshops are held once per month
(4th Wednesday) as a cost effective way to keep up to date on
quality practices, and to network with some of the best quality
professionals in industry. Dinner & 0.3 re-certification units
included. Held in meeting rooms upstairs. See
feedback from past workshops, "... the workshop was AWESOME!",
or "... the best investment I've made in years". Jump
Below to:
Are you required to perform Design Verification and Validation activities?
Are your companies Design V & V practices compliant to the FDA?
Can you answer the following questions? 1. Who is responsible to perform Design V & V activities?
2. What quality tools are needed to perform Design V & V activities?
3. When are accelerated testing methods appropriate?
4. Where can I find the FDA’s Quality System Regulation requirements for V & V
activities?
5. How do I structure test plans & test report documents?
This presentation is for anyone working in any industry that is interested in V
& V but it will place a special emphasis in how the FDA's Quality System
Regulation has put renewed focus on design verification and validation test
practices.
This workshop will give participants an overview of design evaluation and
validation test principles most applicable to the medical technology industry.
Requirements for developing and
executing sound test plans, including some of the statistical and quality tools
needed, will be discussed. Basic principles of accelerated testing will be
explained. Also the documentation aspects of design evaluation and validation
testing will be reviewed with practical suggestions on structuring test plans &
reports.
About Our Speaker:
Henry Posters is a Registered Professional Quality Engineer with extensive
experience in the field of implantable medical devices. He is familiar with
product requirements in the United States and Europe.
Mr. Posters holds a BS degree in Electrical Engineering and an MBA in
Manufacturing Management. He is a senior member of the American Society for
Quality. He is an ASQ certified Quality Engineer, Reliability Engineer, and
Quality Manager.
Dinner
will be served promptly at 5:30 and the program will begin at 6:00 PM
If
you are interested in attending this workshop, please fill out and
submit the following on-line form and bring a check to the meeting, or you can mail this form
with the check
made out to
ASQ, San
Diego Section 0703
to*
spaces are mandatory.