| 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: |
Typical Workshop (4/2002) |
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| Past Workshops | RSVP Form | |
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TOPIC |
Taught By |
Date |
Cost |
Contact |
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"FDA Compliant Design Verification and Validation" |
Hank Posters |
April 23, 2003 |
$50 Members with Reservation, $60 "Non Member/Day of the Event" |
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Special guest talk on V&V P's & Q's by Kim Niles |
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Abstract:
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
Location: Ericsson Building
Time: 5:30 PM – 9:00 PM
Address: 6455 Lusk Boulevard , San Diego, CA92121
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.
Upcoming
Workshops (Chronological Order):
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TOPIC / Link |
Taught By |
Date |
Cost |
Contact |
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|
5S Methods In Depth |
Diane Geldreich |
May 28, 2003 |
$50/$60 |
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Inthinking & Enterprise Thinking Concepts |
William Bellows, Ph.D. |
June 25, 2003 |
$50/$60 |
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"Steven Covey & Time Management Principles" |
Karin Riggs |
July 23, 2003 |
$50/$60 |
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More soon |
August | ||||
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More soon |
September | ||||
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Nov. and beyond |
$50/$60 |
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Hoshin Planning
|
Pete Babich |
Post September or backup |
Special pricing to cover his book |
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Short Run Techniques of SPC Charting |
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Backup |
$50 Members with Reservation, $60 "Non Member/Day of the Event" |
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Past
Workshops (Reverse Chronological Order):
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TOPIC / Link |
Taught By |
Date |
Cost |
Contact |
|
Hank Posters & Guest talk by Kim Niles |
April 23, 2003 |
$50/$60 |
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"Converting a Quality Management System using the Process Approach" |
Roland Kelly &Julie Drysdale |
March 2003 |
$50 Members with Reservation, $60 "Non Member/Day of the Event" |
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Keith Boyle |
Feb. 26, 2003 |
$50 Members with Reservation, $60 "Non Member/Day of the Event" |
Don Griego |
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Jane Marshall |
Jan. 29, 2003 |
$50 Members with Reservation, $60 "Non Member/Day of the Event" |
Don Griego |
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We had no workshop in December 2002 |
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We had no workshop in November 2002 |
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Diane Geldreich |
October 23, 2002 |
$40 Members with Reservation, $50 "Non Member/Day of the Event" |
Don Griego |
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Statistics for Quality Engineering: DOE and other techniques |
Dr. Leonard Perry |
September 25, 2002 |
$40 Members with Reservation, $50 "Non Member/Day of the Event" |
Don Griego |
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James E. Stanley, MS |
August 28, 2002 | $40 Members with Reservation, $50 "Non Member/Day of the Event" |
Don Griego |
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Roger Olson - Partner |
July 31, 2002 |
$40 Members with Reservation, $50 "Non Member/Day of the Event" |
Don Griego |
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The Application and Interpretation of Geometric Dimensioning and Tolerancing (GD&T) |
Michael A. Sandford is the President of Technical Documentation Consultants of Arizona, Inc. |
Wed. June 26, 2002 |
$40 Members with Reservation, $50 "Non Member/Day of the Event" |
Don Griego |
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We had no workshop in May 2002 |
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Diane Geldreich, et.al. |
Wed. April 24, 2002 |
$40 Members with Reservation, $50 "Non Member/Day of the Event" |
Don Griego |
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We had no workshop in March 2002 |
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Dr. Jim McMahon |
Wed. Feb. 27, 2002 |
$40 Members with Reservation, $50 "Non Member/Day of the Event" |
Don Griego |
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Rich Ostrin |
Wed. Jan. 30, 2002 |
$30 |
Don Griego |
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| "Transition to ISO 9001:2000 Without Tears" | Mr. Vinod Kumar, founder President of ISOguru, Inc. | October 24th from 5:30 to 9:00 P.M. |
$30
|
Don Griego |
| Combined meeting & workshop. This 2 hour Workshop on "Regulatory Audits and QSIT". See Sept. meeting topic |
Barbara Moynier |
September 26th from 5:30 P.M. to 9:00 P.M. midweek training opportunity |
$30
|
Don Griego |
| Understanding Engineering Drawings |
Don Griego |
Aug. 2001 |
$30 |
Don Griego |
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GMP & ISO Compliance
Click Here For Information |
|
Refresher
courses held at National University. See our
Education page |
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Click www.pqsinc.org or call, or email sharky.watkins@pqsinc.org
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