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Our section hosts workshops once per month 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 $40.00 investment I've made in years". Jump Below to:

Typical Workshop (4/2002)

This Month's Workshop

Upcoming Workshops

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This Month's Workshop

Our August workshop as outlined below went really well. Our September workshop should be posted here soon.

TOPIC

Taught By

Date

Cost

Contact

“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

Background Information:

The medical device industry has rejected ISO 9001:2000 as too general to be used as a model for medical device manufacturing. A new standard, ISO/DIS 13485:200X is being developed and is now available for public comment. It is expected to be in the final draft stage by fourth quarter this year and released early first quarter of 2003. Medical device companies will have no choice but comply with this to do business internationally, as EN 46001 in conjunction with ISO 9001:1994 become obsolete on December 15, 2003. ISO 13485:1996 will be obsolete with the release of the proposed standard.

Note: I presented a full day workshop in April at a division of Johnson & Johnson in the LA area. There was a great deal of interest.

Outline:

I. The evolution of medical device standards and regulations – this section includes a discussion of the timeline of the development and interrelationship of these standards and regulations.

II. Impact of ISO 9001:2000 – in this section we will discuss the influence this standard has had in bringing about the new ISO 13485. We will explore what is different and what is the same.

III. Global device requirements – discussion about what is needed to do business in various countries with emphasis on Canada and Europe.

IV. A detailed review of ISO/DIS 13485 – during this section we will go through the proposed standard in detail. We will highlight all of the changes and additional requirements that will need to be considered.

V. Implementation considerations – discussion will be about how the new requirements may be implemented. Exercises would be included.

VI. Auditing implications – discussion about how to audit and what auditors will look for to assess compliance.

Speaker biography:

James E. Stanley, MS - Regulatory/Clinical Consultants, Inc.

New office in Sorrento Valley.

CQE, CQA
ISO Lead Assessor
20 years of Quality Management Experience
8 years of medical device experience
4 years of consulting experience

Jim Stanley has extensive experience in quality systems management and development. He has developed many quality systems compliant with FDA regulations, ISO 9001, EN 46001, and ISO 13485. With over 20 year’s experience, Jim has served as Quality Assurance Manager of several divisions of Nellcor Puritan Bennett/Mallinckrodt. He has also been an independent consultant and is now working as the Associate Director of Compliance & Medical Devices for Regulatory Clinical Consultants, Inc. with offices in Kansas City and San Diego.

Jim is ASQ certified as a CQE and CQA. He is also an ISO Lead Assessor and performs certifications with ISO registrars. Jim holds a Master of Science in Industrial Management from Central Missouri StateUniversity.

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.

*Name:
Job Title:
*Email:
*Payment Plan:	$40 Members with Reservation Check or cash at the meeting I have mailed this form with the check $50 "Non Member/Day of the Event" Check or cash at the meeting I have mailed this form with the check Cancellation It's not the day of the event, please cancel me with no penalties. It's the day of the event, please cancel me and contact me of fees.
Member #:	used for the .3 re-certification units
Phone (H):
Phone (W):
Company:
Mailing Address:

Press submit to register for our workshop

Upcoming Workshops (Chronological Order):

TOPIC / Link

Taught By

Date

Cost

Contact

Statistics for Quality Engineering: DOE and other techniques

Dr. Leonard Perry

09-25-02

$40 Members with Reservation, $50 "Non Member/Day of the Event"

Don Griego

Theory of Constraints

Jane Marshall

10-23-02?

$40/$50

Don Griego

Internal Audit Techniques

Diane Geldreich

11-27-02

$40/$50

Don Griego

QFD or Cost of Quality

Keith Boyle

Backup

$40 Members with Reservation, $50 "Non Member/Day of the Event"

Don Griego

Short Run Techniques of SPC Charting

Bill Evans

Backup

$40 Members with Reservation, $50 "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 at: dgriego@digirad.com.

Past Workshops (Reverse Chronological Order):

TOPIC / Link	Taught By	Date	Cost	Contact
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
ISO 9000:2000 Transition	Diane Geldreich, et.al.	Wed. April 24, 2002	$40 Members with Reservation, $50 "Non Member/Day of the Event"	Don Griego
We had no workshop in March 2002
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 24^thfrom 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
Understanding Engineering Drawings	Don Griego	Aug. 2001	$30	Don Griego