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| 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) |
|
This Month's Workshop |
Upcoming Workshops |
|
Past Workshops |
RSVP Form |
This Month's Workshop
|
TOPIC |
Taught By |
Date |
Cost |
Contact |
|
"FDA Compliant Design Verification and
Validation"
|
 Hank Posters
|
April 23, 2003
|
$50
Members with Reservation, $60 "Non Member/Day of the Event"
|
Don
Griego
|
|
Special guest talk on V&V P's & Q's by
Kim Niles |
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):
|
TOPIC / Link |
Taught By |
Date |
Cost |
Contact |
|
5S Methods In Depth |
Diane Geldreich
|
May
28, 2003
|
$50/$60
|
Don
Griego
|
|
Inthinking & Enterprise
Thinking Concepts
|
William Bellows, Ph.D.
|
June 25, 2003
|
$50/$60
|
Don
Griego
|
|
"Steven
Covey & Time Management Principles" |
Karin Riggs |
July
23, 2003
|
$50/$60
|
Don
Griego
|
|
More soon |
|
August |
|
|
|
More soon |
|
September |
|
|
|
|
|
Nov. and beyond |
$50/$60
|
Don
Griego
|
|
Hoshin Planning
 |
Pete Babich |
Post September or backup |
Special pricing to
cover his book |
Don
Griego
|
|
Short Run Techniques of SPC Charting
|
Bill Evans
|
Backup
|
$50
Members with Reservation, $60 "Non Member/Day of the Event"
|
Don
Griego
|
|
If you
or your company has special education needs or special interests in
hosting or presenting a workshop, please contact
Don Griego.
|
|
Past
Workshops (Reverse Chronological Order):
|
TOPIC / Link |
Taught By |
Date |
Cost |
Contact |
|
FDA Compliant Design Verification and
Validation
|
Hank Posters &
Guest talk by Kim Niles
|
April
23, 2003
|
$50/$60
|
Don
Griego
|
|
"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" |
Don
Griego
|
|
Quality Function Deployment (QFD)
|
Keith Boyle
|
Feb. 26, 2003 |
$50
Members with Reservation, $60 "Non Member/Day of the Event"
|
Don Griego |
|
Lean & Theory of Constraints
|
Jane Marshall
|
Jan. 29, 2003
|
$50 Members with Reservation,
$60 "Non Member/Day of the Event"
|
Don Griego |
|
We had no workshop in December
2002
|
|
We had no workshop in November
2002
|
|
Internal Audit Techniques
|
Diane Geldreich
|
October 23, 2002
|
$40 Members with Reservation,
$50 "Non Member/Day of the Event"
|
Don Griego |
|
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 |
|
“ISO 13485, The Global Device
GMP”
|
James E. Stanley, MS
Regulatory/Clinical Consultants, Inc.
|
August 28, 2002
|
$40 Members with Reservation, $50 "Non
Member/Day of the Event"
|
Don Griego
|
|
Lean Manufacturing 101: The
Basics & Getting Started
|
Roger Olson - Partner
Systems Quality, Inc.
|
July 31, 2002
|
$40 Members with Reservation, $50 "Non
Member/Day of the Event"
|
Don Griego
|
|
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 |
|
We had no workshop in May 2002
|
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ISO 9000:2000 Transition
|
Diane Geldreich, et.al.
|
Wed. April 24, 2002
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$40 Members with Reservation, $50 "Non Member/Day of the Event"
|
Don Griego
|
|
We had no workshop in March 2002
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|
Using Excel for Statistics
|
Dr. Jim McMahon
|
Wed. Feb. 27, 2002
|
$40 Members with Reservation, $50 "Non Member/Day of the
Event"
|
Don Griego
|
|
Six Sigma Calculations
|
Rich Ostrin
|
Wed. Jan. 30,
2002
|
$30
|
Don Griego
|
|
"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 - Senior Food and Drug Investigator and her colleagues
|
September 26th from 5:30 P.M. to 9:00 P.M. midweek training opportunity |
$30
|
Don Griego
|
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Understanding Engineering Drawings |
Don Griego
|
Aug. 2001
|
$30
|
Don Griego
|
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GMP & ISO Compliance
|
Sponsored by UCSDE
Free Info
Sessions. Click here
for more info.
or call (858) 882-8018
|
Sarbanes Oxley, ISO, BS, HIPPA,etc.
|
|
Pay now
with credit card or PayPal.
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