While I could write a book covering all the action our section has been engaged in already this year, I'll just list a few of the highlights in hopes that you'll contact me with your offer to join in the fun.  Here's the highlights:

• I moved to Nevada ... ouch... or is it?  I'll still be in San Diego quite often.   

  • Since two board members now live outside of San Diego, our board meetings have now been on line ... (Natalie is in Sacramento).  This seems to be working out rather well and saving money over board meeting dinners of years past.  

  • Gregg Oliver has taken over day to day operations

  • New officers will be elected soon to take office July 1, 2008 

• Kim Niles received a VIP tour of National headquarters.  I've asked him to report on it next month.  

• Kim has also been working with noted Six Sigma author Tom Pyzdek and our regional directors to put together a Six Sigma discussion group in San Diego for May.  Let Kim know if you are interested in helping out with that.

• We have a lot of new educational courses starting soon as well as two workshops being planned.  Keep an eye on the education pages.    

• The San Diego County Office of Emergency Services has invited me to meet with them at 3 pm on the 12^th right before our membership meeting to discuss ways our pool of Quality Professionals can help to prevent the next San Diego firestorm from happening.  

  • For this reason it is very important that everyone attend so we can decide what next steps to take.  I also want to make an announcement of this effort at the section meeting. I think our section membership will be really excited to hear how this has worked out thus far.

• Did you notice last Friday's ASQ fast facts?  Here's a recap:  ASQ to Support San Diego Charity.  To support the San Diego area s recovery from recent wildfires, ASQ will donate $1,000 to the American Red Cross on behalf of the Society and the San Diego Section. Mike Nichols, ASQ president, will present a check to San Diego Section 703 representatives, who were invited to attend the ASQ board reception which is being held in San Diego in February.

  • Our board is planning to match this amount.

  • The ASQ National Board of Directors held the "ASQ Board of Directors 1-week workshop" held at the Westin San Diego last week. Officers from the San Diego section were invited. ASQ National President Mike Nichols presented a check to section 703 Vice Chair Gregg Oliver to be given to the San Diego Red Cross, in recognition of their efforts during the wildfires in October. ASQ San Diego has pledged to make a separate matching donation as well. Gregg Oliver delivered an inspiring 20 minute speech, announcing the San Diego section's intention of working with the San Diego County Office of Emergency Services to investigate the application of Quality Tools to improve their existing system under Doug McCloskey's project leadership. Mike mentioned that ASQ headquarters is open to any help we will need in this project." 

    • The photo below on the left is a photo of Mike Nichols (ASQ President; left), Geraldine Domingo, Jody Suroweic, and Gregg Oliver at the Reception at the Westin. " 

    • The photo on the right is of Laurel Nelson-Rowe (managing director; left), Jody Suroweic, Mike Nichols, and Geraldine Domingo.

Other Announcements

• A few new jobs have recently been posted on our jobs page at http://www.asqsandiego.org/jobs.htm ... and keep sending them in.  

• Don't forget to check out our sponsor pages.  Great courses and products being offered!!  See links at the bottom of this email.   Also note that the MSBQA program at SDSU has a Change and Improvement management course starting January 7, 2008.  See more at http://interwork.sdsu.edu/cbbd/bqs/bqs.htm  

• Don't forget to check out other local events on our local event calendar. 

This Month's Meeting

 

Feb. 12, 2008	"Practical Considerations for Implementing Quality Systems"	Andrew Campbell  Director of Quality Assurance  858-605-1744 andrewc@qualpartners.com  www.qualpartners.com
		Pre-meeting-clinic this month on Certification; lead by Rich Ostrin, Section Certification Chair

 

 

Abstract

 

This presentation represents a compilation of 20 years of bumps, bruises, and triumphs in the design and implementation of Quality Systems in FDA-regulated companies. 

 

Simple, effective tools to design, remediate, and implement Quality Systems will be presented and discussed.  Emphasis will be on practical considerations at all stages, from project initiation to post-implementation monitoring. Humorous anecdotes and audience participation exercises will also be utilized to illustrate key points.

 

 

Biography

 

Andrew Campbell, Sr. Quality Compliance Associate with Quality Compliance Partners, Inc. specializes in pharmaceutical Quality Systems analysis, design, and implementation. His broad understanding of quality operations comes from 18 years of Quality Compliance and Quality Systems experience ranging from early phase development through commercial manufacturing operations. 

 

Andrew holds a B.S. in Chemistry from the University of California at Davis, and has held several management-level Quality Assurance positions, most recently as Director of Quality Systems for a San-Diego based pharmaceutical company with several commercial products. 

 

Andrew has led Quality Compliance and Quality Systems teams in both integrated manufacturing and "virtual" environments. He has had overall responsibility for developing, implementing, and maintaining Quality Systems in the areas of GMP/GLP/EU/DEA Compliance, Product Release, GMP Auditing, GMP Training, Product Complaints, Electronic Document Management Systems, and Regulatory Inspection Management, and several other key Quality Systems. 

 

Andrew has experience with a range of dosage forms, with particular emphasis on aseptic manufacturing. He is a skilled GMP auditor, and has served as the lead escort for several FDA and EMEA inspections. He has authored numerous Quality System SOP's, Annual Product Reviews, and Investigation Reports. He also coordinated the Quality activities related to a complex and lengthy product recall investigation. 

 

As a consultant, Andrew has a keen ability to analyze complex problems and apply solutions which balance regulatory and business needs, while designing those solutions to be simple and practical. With unparalleled attention to customer needs, he is known as a person who "gets the job done"- on time, and with exceptional quality.

 

 

Meeting details are as follows:

Meeting Details
RSVP Required	Please use the RSVP form on our meetings page.  Attendance fee includes a delicious dinner.
Meeting Date	Tuesday February 12, 2008 (2nd Tuesday of the month)
Agenda	5:15 pm             Registration & Happy Hour Begins 5:45 pm             Pre-meeting-clinic  6:10 pm             Dinner  6:35 pm             Announcements  6:45 pm             Main program   7:45 pm             Raffle and Speaker Prizes 7:55 pm             Adjourn
Menu	Great buffet meal.  Typically a special selection of Pasta and Basil chicken.
Price RSVP Form Here
	These are sponsor subsidized prices	Dinner With RSVP	Dinner Without RSVP	No Food Arrive Late
	ASQ Student Members	$10	$12	Free
	Regular Members	$20	$22	Free
	Non-Members	$24	$26	Free
Door Prizes	We averaged $185 in door prizes per meeting last year!!
Dress	Nice Casual
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
Parking	Ample free parking

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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 send them to our Education Chair so he can 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. 

 

Certification Types and Links to "Body of Knowledge", & Additional Information	Application Deadline	Exam Dates
CQT - Quality Technician CRE - Reliability Engineer CQI - Quality Inspector CMQ/OE - Manager Q&Org.Ex. CSSBB - Six Sigma Black Belt CHA - HACCP Auditor CBA - Biomedical Auditor	Every January and August Next is August 15, 2008 Then again on: January 9, 2009 August 14, 2009	Every March & Oct. Next is March 1, 2008 Then again on: October 18, 2008 March 7, 2009 October 17, 2009
CQE  - Quality Engineer CQA - Quality Auditor CSQE  - Software Quality Eng. CQIA - Q Improvement Associate CCT - Calibration Technician CQPA - Quality Process Analyst CSSGB - Six Sigma Green Belt	Every April and October Next is April 4, 2008 Then again on: October 3, 2008 April 10, 2009 October 9, 2009	Every June & Dec. Next is June 7, 2008 Then again on: Dec. 6, 2008 June 6, 2009 Dec. 5, 2009

 

Upcoming Workshops and Modular Courses

For future month workshops see upcoming workshops.

 

TOPIC	Taught By	Date;Tm;Loc	Cost	Contact
Two workshops currently in planning.  One on Six Sigma select topics and one on Models, methods, and tools for quality and reliability.  Stay tuned.
Our workshop coordinator is looking for speakers, interesting topics, and a meeting location.  Contact Jenny Gossett (CQA-CBA), Director of Quality; e-mail: asq703workshop@yahoo.com

 

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Newsletter Sponsors

 

Our newsletter sponsors this month are:

 

Lean Six Sigma & Green Belt Training Click Here for More Info.

Click here.  ISO 9001: 2000 & AS 9100   Audit Training March 2008 in SD.

See Schedule of Numerous Events!   Lean Six Sigma Class Just Started - Act Now!   University of California, San Diego Extension Six-Sigma Black-Belt     A Black-Belt Professional Certificate Program

Click on picture

Sarbanes Oxley, ISO 9000, BS 7799 (ISO 17799), HIPAA...  Click Here For Information or see http://grantrothbard.com/

 

Be Our Sponsor - Contact Kim Niles

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If you enjoyed reading this month's San Diego ASQ Section 703 Meeting Newsletter, please share it with a colleague.   

 

TO CHANGE YOUR ASQ E-MAIL PREFERENCES:

• Visit http://www.asq.org

  • Click on the "ASQ Membership Sign-in" button and login in using your member number and password.

  • Click on the "My Account" button and choose the "Change work/home addresses and e-mail" option to update your information and preferences.

  • Check (or uncheck) the option entitled "My Section - I would like to receive e-mails from my Section about upcoming events, newsletters and other Section business."

• If you need additional help, e-mail ASQ Customer Care at help@asq.org, or call 1-800-248-1946

Sincerely, Kim Niles - Quality Engineer & Communications Chair  

See All Officer Contacts 

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Past issue archives;  San Diego's Quality Source;  © 2007 asqsandiego.org.