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ASQ
SAN DIEGO SECT. 703 MEETING MAILING
The first of two monthly mailings from our section
Visit Our Site at:
http://www.asqsandiego.org or
www.asqsd.org
American Society for Quality
June 6, 2006
Vol. XVIII, #12
This is our 113th electronic newsletter.
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Instructions for modifying mailing list or membership status see bottom.
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IN THIS ISSUE
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OUR SPONSORS
Sponsor: USD
Sponsor: GMP Label
Sponsor: QPRS - Three new
courses
Sponsor: UCSD
Extension
MESSAGE FROM THE CHAIR
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"Taking Action"
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This evening I voted. Voting is one form of taking action. It
takes a lot of work to read up on the candidates, schedule time out of a
very busy day, stand in line, fill out the paperwork, then vote while
knowing that all that effort really is statistically more of a symbolic
gesture than anything. However,
collectively we know that the best
way we all can take action for the betterment of society is to vote.
We walk off proudly wearing that "I voted" sticker.
Tonight was different however because as I was scanning the ballot I
noticed a good friend of ours ...
Pete Babich is running for County Central Committee 75th Assembly District
... what ever that is. WOW,
talk about taking action.
Pete's what this country really needs,
a take quality action kind of guy.
For those of you that don't remember, Pete gave us a workshop on Hoshin
Kanri in August of 2004. He also wrote a book on the subject and
attends our meetings every once in a while. See more on that
workshop at
http://www.asqsandiego.org/archives/3hrws_PeteB_Hoshin_0804.htm
Pete: Good luck buddy, we're
backing you up on this one. We look forward to watching you show how
quality disciplines can be applied to government. We're ready to
watch you show the country what ethics are really all about. We're
ready to support you all the way to the Presidency of the USA!! ...
<smile>.
Other Key Announcements
This Month's Meeting
Our
May meeting went well (see details here).
Our June meeting will be as follows:
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Joint meeting with
the ASQ Biomedical Division and ASQ Palomar Section 708 |
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June 13, 2006 |
"PREPARING FOR AND
MANAGING FDA INSPECTIONS ROUNDTABLE DISCUSSION" |
James E. Kozick
Principal Consultant
Kozick Consulting
San Clemente, CA
Voice/FAX: (949)-492-6609
Cell: (949) 310-5925
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Note that this will be a
joint meeting with the ASQ Biomedical Division and ASQ Palomar Section 708.
This will likely be double or triple our normal group size.
Abstract
This Roundtable Discussion will utilize the synergy of a well-versed Subject
Matter Expert along with your Regional Industry Peers to explore the aspects
of an effective FDA inspection strategy. Please submit your discussion
questions on-line and help make this a valuable experience for everyone.
Special pricing, dinner only, and RSVP timelines apply for this event. See details
below.
Speaker Biography
Jim Kozick, Principal
Consultant, Kozick Consulting, specializes in providing Regulatory and
Compliance Consulting Services to the medical device and pharmaceutical
industries. Mr. Kozick provides the full spectrum of compliance and
regulatory consulting services which include, but are not limited to:
compliance assessments, training, regulatory strategies, FDA communications,
pre and real time FDA inspectional assistance, response to regulatory
challenges/actions, and assessments under Attorney-Client Privilege.
Prior to forming Kozick Consulting in 2005, Jim served both as a Principal
Consultant and as the Director of Medical Device Compliance Consulting with
PAREXEL Consulting (formerly KMI), an international provider of regulatory
compliance, validation, quality systems, and information system services to
the pharmaceutical, medical device and biopharmaceutical industries. He
served in this capacity from 2001 to 2005.
Mr. Kozick joined PAREXEL Consulting in 2001 after a 29-year career with the
FDA in the Los Angeles District which included experience as a FDA
Investigator, Supervisory Investigator, and Director of Domestic
Investigations. He directed the investigative/enforcement activities of
seven Supervisory Investigators and seventy-five FDA Field Investigators
comprising the largest field investigative operation within the FDA. He
developed local investigative operational policies/procedures/strategies in
the enforcement of FDA statutes and regulations encompassing all FDA
regulated industries. He established and maintained effective working
relationships with virtually every component within the FDA Headquarters and
Field organization including, but not limited to all District Offices, all
National Centers and the FDA Office of Criminal Investigations. He worked
closely with local industry associations to develop and execute outreach
programs, workshops/seminars, and training programs covering a wide variety
of FDA-related topics. During his last years with FDA, he served on extended
temporary duty as the Acting Director, Los Angeles District, exercising
ultimate responsibility and final authority for all District operations.
While with FDA and Parexel Consulting, he has given numerous presentations
on a variety of regulatory and compliance topics.
Jim received his Bachelor of Science degree from St. John’s University,
Collegeville, Minnesota. He is a member of the Regulatory Affairs
Professional Society (RAPS), and the Orange County Regulatory Affairs
Association (OCRA).
James E. Kozick
Principal Consultant
Kozick Consulting
San Clemente, CA
Voice/FAX: (949)-492-6609
Cell: (949) 310-5925
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Meeting Details
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RSVP Required |
Please use the
RSVP form below. Attendance fee includes
a delicious dinner. |
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Meeting Date |
Tuesday June 13, 2006 (2nd Tuesday of the month) |
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Agenda |
5:15 pm
Registration & Happy Hour Begins
6:00 pm
Dinner
6:35 pm
Announcements
6:45 pm
Main program
8:55 pm
Adjourn
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Menu
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Great buffet meal.
Special selection of Pasta and Basil chicken.
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Price |
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These are
sponsor
subsidized prices |
Dinner With RSVP |
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Regular Members
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$20 |
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Non-Members |
$30 |
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| Door Prizes |
We averaged $185 in door prizes per
meeting last year!! |
| Dress |
Nice Casual
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| Location |
This month we're at:
Country Inn & Suites By Carlson
(formerly Prime Hotel, formerly Wyndham San Diego North).
5975 Lusk Boulevard, San Diego CA 92121. Their Phone: (858) 558-1818
see map here
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| Parking |
Ample free parking
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Note that we will be using a
different system this month.
Limited seating: First 60 registrants.
(0.3 R.U.s Awarded)
Special pricing: Members - $20.00; Non-members - $30.00
Buffet (Chicken/Veg.Pasta), Dessert, and Beverage
For more information, contact: Carole White at e-mail:
carole.white@respironics.com
or Karen Liu at kliu@nuvasive.com
To register,
click on or type
http://www.acteva.com/booking.cfm?bevaid=111568
The last day to register is June 8, 2006
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EDUCATIONAL PROGRAMS UPDATES
Our section proudly sponsors a variety of educational and professional
training
opportunities. See our
main education page for more details.
Classes to be Held This Month
See classes that are under way this month on our
Refresher page and
Modular page.
Keep signing up for any courses you'd
like to take and we will keep adding more so that perhaps the class you
want will be held next month. If you have any special requests,
please make them also as we will try to accommodate you.
Current Exam Dates Schedule
Certification exams are held in member company meeting rooms around San
Diego and administered by proctors. They are held on Saturday
mornings twice per year as shown in the table below.
Note that these dates
don't include special quality conference tests.
Main ASQ certifications page.
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Certification Types and Links to "Body of
Knowledge", & Additional Information |
Application Deadline
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Exam Dates
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CQT -
Quality Technician
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CRE -
Reliability Engineer
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CMI -
Mechanical Inspector
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CQM -
Quality Manager
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CSSBB -
Six Sigma Black Belt
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CHA -
HACCP Auditor
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CBA - Biomedical Auditor
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Every January and August
Next: August 18, 2006
Then again on:
January 12, 2007
August 17, 2007 |
Every March & Oct.
Next is October
21, 2006
Then again on:
March 3, 2007
October 20, 2007 |
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CQE - Quality Engineer
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CQA
- Quality Auditor
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CSQE
- Software Quality Eng.
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CQIA
- Q Improvement Associate
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CCT
- Calibration Technician
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CSSGB -
Six Sigma Green Belt
Every April and October
Next is October
6, 2006
Then again on:
April 6, 2007
October 5, 2007
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Every June & Dec.
Next is June 3,
2006
Then again on:
December 2, 2006
June 2, 2007
December 1, 2007 |
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Upcoming Workshops and Modular Courses
For future month workshops see
upcoming workshops.
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TOPIC |
Taught By |
Date;Tm;Loc |
Cost |
Contact |
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New Medical device workshop coordinator is looking for
speakers, interesting topics, and a meeting location. Contact
Jenny Gossett (CQA-CBA),
Director of Quality
ALFA SCIENTIFIC DESIGNS, INC.
POWAY, CA 92065
PHONE: 858.513.3888 x 314
e-mail:
jgossett@alfascientific.com
We are close to being able to present a two hour
workshop on Gage
R&R. Stay tuned. |
Newsletter Sponsors
Our newsletter sponsors this month are:
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Lean
Six-Sigma: Green-Belt, Black-Belt and Master Black-Belt Workshops
Click
Here for More Information.
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Lean Six Sigma Starting Soon - Act Now!
University of California, San Diego Extension
Six-Sigma
Black-Belt
Newly Revised Program
A Black-Belt Professional Certificate Program
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Click on picture
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Sarbanes Oxley
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ISO 9000
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BS 7799 (ISO 17799)
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HIPAA, etc.
or see
http://grantrothbard.com/
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Six-Sigma & Lean
Providing you the roadmap for successful Implementation
Hands-on workshops
- Lean Six Sigma Black Belt
- NEW
- Lean Kaizen Simulation One-Day
- Six Sigma Black Belt
-
At your company.
Call now.
Location: San Diego, CA
Call
858 566 6432 or
info@qprs.com
QPR - Quality and Productivity Resources -
http://www.qprs.com/
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If you enjoyed reading this month's San Diego ASQ Section 703 Meeting
Newsletter, please share it with a colleague.
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PREFERENCES:
Sincerely,
Kim Niles - Quality Engineer & Communications Chair
See All Officer
Contacts
Past issue archives;
San Diego's Quality Source; © 2006
asqsandiego.org.
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