San Diego Sect 703

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Workshops are held once per month (usually 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. 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

No workshop for February due to our 15 society joint meeting with NEW 2004. RSVP by paying $37 by credit card.

No workshop for January due to the non-normal joint meeting date with APICS
No Workshops for November and December due to the holidays.

Some of the educational courses follow a workshop format and are being held on the third week of the month as long as enough people sign up by the beginning of the month (see educational course list).

Here is information regarding our October workshop.

TOPIC	Taught By	Date	Cost	Contact
“ISO/FDIS 13485, The Global Device GMP” updated to include CMDCAS	James E. Stanley, MS Regulatory/Clinical Consultants, Inc.	October 29, 2003	$50 Members with RSVP, $60 "Non Member / Day of the Event"	Don Griego

Abstract

This workshop will be an extension of the monthly meeting and will follow a similar format as his very successful workshop in 2002 in that you will be doing a fair amount of the work but leave with a lot. If you attended his last course, don't worry, the content will be different.

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/FDIS 13485:2003 is complete and due to be released. There are many interesting implications and transition plans involving Europe, Canada, and the rest of the world.

Outline as follows:

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/FDIS 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.

About Our Speaker

James E. Stanley, MS, CQE, CQA, ISO Lead Assessor

CMDCAS Certified Auditor (Canadian Medical Device Conformity Assessment System)

20 years of Quality Management Experience
9 years of medical device experience
5 years of consulting experience

Dinner will be served promptly at 5:30 and the program will begin at 6:00 PM

Location: Most likely the Ericsson Building but still need to confirm.

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:
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*Payment Plan:	$50 Members with Reservation Check or cash at the meeting I have mailed this form with the check I will pre-pay using my credit card below shortly $60 "Non Member/Day of the Event" Check or cash at the meeting I have mailed this form with the check I will pre-pay using my credit card below shortly Cancellation It's not the day of the event so please cancel me with no penalties or reimbursement expected. It's not the day of the event, please reimburse me for money paid. It's the day of the event, please cancel me and contact me of fees.
Member #:	used for the .3 re-certification units
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Press submit to register for our workshop. By submitting this form you are submitting your RSVP for this month's workshop unless the date for this month's workshop has passed.

After submitting your RSVP by hitting the "submit registration" button above, return here and click on the appropriate PayPal button below to pay now. If the class is cancelled or you submit a cancellation within 24 hours, your money will be refunded to you in full.

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Upcoming Workshops (Chronological Order):

TOPIC / Link

Taught By

Date

Cost

Contact

ISO 13485

James E. Stanley, MS

Regulatory/Clinical Consultants, Inc.

October 29, 2003

$50/$60

Don Griego

No workshop in November due to Thanksgiving holidays

No workshop in December due to Christmas holidays

"better thinking about thinking"

Also see past talk:

Inthinking & Enterprise

Thinking Concepts

William Bellows, Ph.D. with Inthinking

January 28, 2004

$50/$60

Don Griego

Open

Feb. and beyond

$50/$60

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
Overview of Strategic Planning with Hoshin Kanri	Pete Babich	September 24, 2003	$50/$60	Don Griego
"Combining Lean and Six-Sigma"	Keith Boyle	August 27, 2003	$50/$60	Don Griego
"Steven Covey, Change, & Time Management Principles"	Karin Riggs	July 23, 2003	$50/$60	Don Griego
Inthinking & Enterprise Thinking Concepts	William Bellows, Ph.D. with Inthinking	June 25, 2003	$50/$60	Don Griego
5S Methods In Depth	Diane Geldreich	May 28, 2003	$50/$60	Don Griego
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
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