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October 12th, 2015

Four Ways to Use Apprentices to Improve Food Quality

There are Four Ways to Use Apprentices: to help reduce the risk of a recall, help pass third party certification audits, fix root causes of complaints, and reduce the cost of manufacturing. The impact on your business bottom line can be tremendous. Here are some ways apprentices are currently being used by our clients:

  • Apprentices can be used to pass third party certifications. This would allow you to land additional clients (make a list). Retailers and other manufacturers often require their Read the rest of this entry »
September 30th, 2015

Director of Quality GCP in San Diego, CA

We are searching for a Director of Quality GCP in San Diego, CA for a client in Phase III Trials. Candidates must have at least 4 years of experience in GCP to be considered.

Read the rest of this entry »

August 17th, 2015

FSMA Compliance Workshop 2015


FSMA Compliance Workshop

Download the PDF flyer

FSMA will impact your food business. Find out how and what to do about it. This is a free half day workshop on Food Safety and Modernization Act (FSMA) compliance.

Breakfast and refreshments are sponsored by the American Society for Quality (ASQ) Food, Drug & Cosmetic Division, the Quality Leaders Network (QLN) Food Group, RxRS Apprenticeship Program and Food Safety Net Services.


FSMA is designed to ensure food quality from the farm to fork. FSMA requires all Read the rest of this entry »

July 30th, 2015

Apprentices Available

Apprentices available to build a fresh new pool of talent in Quality, Regulatory, Clinical and Medical roles for Food, Biotech, Pharmaceutical and Medical Devices. Our grants cover part of the cost of training and employing apprentices while they work toward an industry certification, typically one or two years.  We currently have two Read the rest of this entry »

March 10th, 2014

ASQ March 2014 Roundtable – Risk Based Environmental Monitoring (EM)ASQ Biomedical Division

This message is sent by the Southern California Discussion Group of the Biomedical Division of ASQ of the American Society for Quality as a benefit of your membership.


The Southern California Discussion Group of the ASQ Biomedical Division Presents:

Risk Based Environmental Monitoring (EM)  

How to use risk to ensure your EM Program is value added & efficient

           An Industry Roundtable Discussion   


Tuesday, March 25, 2014
5:30pm to 8:30pm Read the rest of this entry »

January 14th, 2014

Ensuring Success with Your Lean Initiative

Tools and Techniques for Driving Change

The Courtyard by Marriott Tuesday January 14, 2014@ 6:00 PM. Read the rest of this entry »

October 16th, 2013

Risk Management

Orange County Regulatory Affairs Discussion Group

Thursday, November 14, 2013


Irvine Marriott

18000 Von Karman

Irvine, CA  92612

949-553-0100   Read the rest of this entry »

August 30th, 2013

Global Supplier Management

Evening Event

Global Supplier Management:

Share and Learn Best Practices From Industries with a Long-Standing History of Robust Supplier Quality Programs

Orange County Regulatory Affairs Discussion Group
Tuesday, September 17, 2013 Read the rest of this entry »

May 9th, 2013

Boost Your Brand: Soft skills are vital in today’s workplace

by Rosemarie Christopher

In an era when many workplaces are in flux, it may seem like there is little opportunity to build your personal brand and influence organizational culture. I would argue there’s no better time to do so than when there is momentum for change already building around you.

Your personal brand is your style. It is composed of your values, abilities, strengths and limitations. These denominators influence how you put your skills and experience to work. The most successful employees, knowingly or not, align their personal brands with their organizations’ cultures.

Change causes a degree of Read the rest of this entry »

April 11th, 2013

2013 Workshop – Marketing of FDA Regulated Products

FDA Centers, FDA Los Angeles District Office and the Orange County Regulatory Affairs Discussion Group Present The 16th Annual FDA-OCRA Educational Conference

June 12-13, 2013

Irvine Marriott
18000 Von Karman Avenue, Irvine, CA 92612 (949) 553-0100

The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA and OCRA, that affords you maximum interaction with both Los Angeles District and Washington-based FDA personnel. Over the years, the collaborative efforts of FDA and OCRA have brought FDA and Industry staff together for this Educational Conference.

Who Should Attend
* Regulatory Affairs/Compliance
* Clinical Affairs/Auditors
* Legal Staff
* Quality Affairs/Quality Control
* Marketing & Advertising
* Product Development
* Consultants & Analysts
* Operations & Management
Keynote Address:
What Went Wrong?
Tales from FDA’s Office of Criminal Investigations (OCI)
Special Agent Keith Hadley, from FDA’s Office of Criminal Investigations, will discuss criminal aspects of non-compliance.

Plenary topics:
* Food & Drug Administration Initiatives for 2013 and “Hot” Topics:
An Agency Perspective
* FDA and FTC Guidance on Social Media:
Innovative Marketing v. Control
* Border Protection: What happens if Your Product is Imported or
There are Suspicious Imports?
* Inspection Mitigation: Avoiding Escalation
* Business Disruption & Resumption Planning After a Disaster:
Real Life Experience and Agency Expectations
* Federal and State Marketing: Sunshine Laws
* Q&A Panel Sessions with all Speakers

Three Separate Breakout Sessions:
1. Medical Devices & IVDs:
* CDRH Update: Hot Topics, Changing Guidance & Expectations,
Partnering: The MDIC Experience
* Federal and State Marketing: Sunshine Laws
* UDI: Implementation and Impact on Industry
* Clinical Trials for Medical Devices: Key Priorities and Activities
* Case for Quality: What are Responsibilities of
Manufacturers/Distributors and FDA’s Next Steps
2. Drugs/Biologics/OTC/Generics:
* Marketing Applications: FDA Review Practices and
Preparation of Global CMC Submissions
* Generic Drugs and Biosimilars Update
* Quality by Design: How Well does Pharma Meet
Deming’s 14 Points?
3. Food/ Dietary Supplements:
* CFSAN and Industry Update
* GMP Issues: Updates, Inspections, Recent Enforcement Activity
* Labeling and Claims
* Dietary Supplements Case Studies and Expert Panel Discussion

Register Online
Be sure to log on or create a new user profile before registering


Wednesday, June 12, 2013

7:00 – 8:00 am
Registration and Continental Breakfast

8:00 – 8:30 am
Opening Remarks by Conference Chairs and OCRA President
Alonza E. Cruse, B.S., District Director, FDA Los Angeles District
Regina O’Meara, Principal, Global IVD Regulatory Consulting
Ginger Clasby, VP Clinical & RA, Transcend Medical, Inc.
8:30 – 9:20 am
Keynote Address:
Real Life Stories from FDA’s Office of Criminal Investigations
Regina O’Meara, Principal, Global IVD Regulatory Consulting
Keith Hadley, Special Agent, FDA’s Office of Criminal Investigations (OCI)
Agent Hadley will discuss criminal aspects of non-compliance.

9:20 – 9:45 am

9:45 – 10:45 am
Food & Drug Administration Initiatives for 2013 & “Hot” Topics:
An Agency Perspective
Alonza E. Cruse, B.S., District Director, FDA Los Angeles District
FDA Speaker Invited
10:45 – 11:45 am
FDA and FTC Guidance on Social Media:
Innovative Marketing v. Control
Michael J. Wagner, Esq., Regulatory Counsel, Focus Diagnostics
FDA Speaker Invited
Eric Goldman, Professor of Law and Director of the High Tech
Law Institute, Santa Clara Law School
This session will cover the following on social media:
* Agency current expectations
* Status of FDA Guidance
* Tools available to monitor social media
* Online Accountability for manufacturers, distributors and packers
* Using Links on the Internet
11:45 am – 1:00 pm

1:00 – 2:00 pm
Inspection Mitigation: Avoiding Escalation
Yasamin Ameri, RAC, Consultant, Quest International Consulting
Dr. Raymond W. Brullo, DPM, FAPWCA, Compliance Officer
FDA Los Angeles District
Jack Sorokin, Esq. Invited
This session will cover the following:
* Addressing potential findings during an inspection
* Responding to inspectional findings
* Meeting with the District
* Estimating Agency expectations and meeting them
* Not all inspections go smoothly and the are different levels of findings
* How does a firm ensure that corrective actions meet the FDA expectations and what are some practical tips for avoiding enforcement escalations

2:00 – 3:00 pm
Business Disruption & Resumption Planning After a Disaster:
Real-Life Experience and Agency Expectations
Esther Y. Kim, Esq, Director of Legal/Compliance, Pharmavite LLC
Del Stagg, PhD, Regulatory Affairs and Quality Consultant
Tanya Malais, National Emergency Response Coordinator, FDA
Robert Takemura, Partner, MLC & Associates, Inc.
This session will cover:
* Identifying potential disasters
* Business impacts following a disaster
* FDA expectations after a disaster

3:00 – 3:15 pm

3:15 – 4:15 pm
Border Protection – What Happens if Your Product is Imported or There are Suspicious Imports?
Linda Hartley, Program Support Specialist, FDA Los Angeles District
Dan Solis, Director of Import Operations, FDA Los Angeles District

4:15 – 5:00 pm
End of Day Open Panel Discussion with All Speakers
James R. Lusk, RAC, Principal, Quality Systems International
5:00 – 8:00 pm
After Conference Reception
OCRA’s Member Appreciation Night
All attendees invited at no additional cost
Click Here to Download the Registration Form

Thursday, June 13, 2013
7:00 – 7:50 am
Networking Breakfast
Attendees will be broken into interest groups to discuss and strategize current industry challenges. We will have separate tables for the following groups:

* Medical Devices
* IVDs
* Drugs and Biologics
* Dietary Supplements

Note: The remainder of the day will be breakout sessions. There are three tracks to choose from:
Medical Devices and IVDs
Drugs, Biologics, OTC and Generics
Food and Dietary Supplements

Medical Devices and IVD
Breakout Sessions
8:00 – 9:15 am
Session #1: CDRH Update
FDA Speaker Invited
Mark DuVal, JD, President, DuVal & Associates
* Hot Topics
* Changing Guidance and Expectations
* Partnering: The Medical Device Consortium Experience

9:15 – 10:30 am
Session #2: Federal and State Marketing: Sunshine Laws
Elaine Messa, Director, Medical Device Quality Systems
Industry Speakers Invited
* What are Sunshine Laws?
* Reporting responsibilities of manufacturers
* Elements of marketing compliance plan
* What about the future and federal pre-emption?
* Covers marketing, sales and distribution
* Q & A
10:30 – 10:45 am

10:45 am – 12:15 pm
Session #3: UDI (Unique Device Identifier):
Implementation and Impact on Industry
James “Rusty” Lusk, Principal, Quality Systems International
FDA Speaker Invited
Dawn Fowler, Sr. Manager of Global Labeling/Document Control,
Everything you ever wanted to know, and more, about UDI
We know that:
* Not all suppliers are the same
* Not all manufacturers are the same
* Not all users are the same
* Not all points of use are the same

We also know that all the above and more, have a need to share the identical information across their points of contact. The UDI is the glue that binds the information into a format that is universally understandable and instantly available at all there interfaces.
Different needs may have different approaches:
* I have one high product. Why all the fuss?
* I have a bazillion sku’s- where do I start?

This session will cover:
* Format Options- why chose one over the other?
* General structure requirements
* Equipment Options
* Implementation successes and pitfalls
* Big Company versus Small Company approaches
* How much will this cost?

12:15 – 1:00 pm

1:00 – 3:00 pm
Session #4: Clinical Trials for Medical Devices
Ginger Clasby, VP Clinical & RA, Transcend Medical, Inc.
Terrie Hopton, Mgr, Business Development, Promedica International
James R. Fleckenstein, Investigator, FDA, Los Angeles District
Christian Burns, Director, Clinical Operations & Marketing, ClinEdge
Lucinda Marinus, Clinical Data, Manager, Transcend Medical
Jodi Aiken, VP, Global Clinical Affairs, Transcather Heart Valve
Therapy, Edwards Life Sciences
In this session, we will discuss several key priorities and activities associated with planning and implementing medical device clinical trials, with an emphasis on:
* Unique considerations associated with finding and recruiting study subjects to participate in medical device clinical trials
* Considerations and best practices for collecting and analyzing clinical study data
* Risk-based monitoring of study progress and conformance with regulatory requirements

3:00 – 3:15 pm

3:15 – 4:15 pm
Session #5: Case for Quality
Moderator: Eri Hirumi, RAC, Regulatory Affairs Manager, Beckman Coulter, Inc.
Speakers: FDA Speaker Invited
This session will cover:
* Background of the Initiative
* Why it’s important
* What are responsibilities of manufacturers and distributors?
* FDA’s next steps
Drugs, Biologics, OTC and Generics Breakout Sessions

8:00 – 9:30 am
Session #1: Marketing Applications: FDA Review Practices and Preparation of Global CMC Submissions
Cindy Fisher, PhD, RAC, Associate Director, Regulatory Affairs, Vical
Industry Speaker Invited
What does FDA look for in marketing applications? A CBER review team member will provide insights into how FDA reviews marketing applications and helpful hints on making your application process run more smoothly.
In today’s global economy, many companies are filing products internationally. With varying in-country requirements and varying IP protection around the world, what are the best practices for managing global CMC submissions?
This session is sponsored by the OCRA CMC Discussion Group.

9:30 – 9:45 am

9:45 am – 12:00 pm
Session #2: Generic Drugs and Biosimilars Update
Michael A. Swit, Esq., Special Counsel, Duane Morris, LLP
FDA Speaker Invited
With the enactment of the Generic Drug User Fee Act (GDUFA), FDA’s Office of Generic Drugs (OGD) may finally have the resources it needs to address both the significant backlog in pending applications and the timelines for approval of generic drug applications. This session will explore how OGD is marshaling these new resources and dealing with other key issues evolving in the generic drug approval process, including citizen petitions challenging generic approval standards and a potential regulation that would impose new pharmacovigilance duties and labeling revision obligations on generic manufacturers. For anyone concerned with generic drugs, whether from a brand or generic perspective, this is an essential session.

12:00 – 1:00 pm

1:00 – 4:15 pm
Session #3: Quality by Design (QbD): How Well Does Pharma Meet Deming’s 14 Points?
Ali M. Afnan, PhD, President, Step Change Pharma, Inc.
FDA Speaker Invited
Kevin R. Cahill, Executive Director, The W. Edwards Deming Institute
Ali M. Afnan, PhD, President, Step Change Pharma, Inc.
Michelle Howard-Sparks, Associate Director of Solid Formulations
Millenium Pharmaceuticals Invited
This session will delve into the application of W. Edwards Deming’s 14 Points for Management to the pharmaceutical industry. In the first half of the session, Kevin Cahill, VP of The Deming Institute and Deming’s grandson, will provide a primer on the Deming’s 14 Points and the philosophy behind them. The second speaker, Ali Afnan, will discuss the applicability and incorporation of Deming’s total quality management approach in the pharmaceutical arena.
In the second half of the session, the FDA will examine the application of statistical quality control techniques to ensure the quality of pharmaceutical products. Finally, an industry speaker will examine the incorporation of Deming’s concepts to the management of development and risk in a pharmaceutical setting.

2:30 – 2:45 pm

QbD Session continues after the break.
Food/Dietary Supplements
Breakout Sessions

8:00 – 10:00 am
Session #1: CFSAN and Industry Update
Vicki Whitsitt, Mgr, Scientific/Regulatory Affairs,
Natural Products Association
FDA Speaker Invited
Cara Welch, PhD, VP Scientific/RA Natural Products Association
Michael McGuffin, President, American Herbal Products
Association (AHPA) Invited
This session will feature an update from FDA on industry hot topics their current priorities and hear from two industry associations address the challenges facing dietary supplement companies both on Capitol Hill and on the regulatory front. While GMPs continue to be in the forefront, it’s not just about GMPs – speakers will also touch topics such as adverse event reporting, the draft NDI guidance, FSMA proposed rules, import/exports, adulterated ingredients, etc.

10:00 – 10:15 am

10:15 – 11:45 am
Session #2: GMP Issues
Timothy Stewart, PhD, Consultant, QSD Consulting Group
FDA Speaker Invited
Cindy Beehner, President, QSD Consulting
This session features an update from FDA on its recent GMP-related enforcement activities and inspection findings and insight from an industry consultant about addressing the most common problems and how to effectively respond to 483 observations.

11:45 am – 12:45 pm

12:45 – 2:30 pm
Session #3: Labeling and Claims
FDA Speaker Invited
Industry Attorney Invited
Supplement labels and claims continue to be a concern to FDA and a source of numerous warning letters. Hear from FDA about the basic regulatory requirements for product labeling and claims for your products. The industry attorney will discuss how to properly position your product in the marketplace, discuss Prop 65 issues, and discuss how product labeling is causing companies to become part of class action suits.

2:30 – 2:45 pm

2:45 – 4:15 pm
Session #4: Dietary Supplements Case Studies
and Expert Panel Discussion
All Speakers Are Asked To Join the End of Day Panel
This session will begin with a group activity of case studies on various scenarios related to current industry issues. The individual groups will share summaries of their case studies, and then it will be open to discussion from the group as a whole and input from the expert panel of speakers.

About OCRA
OCRA, Orange County Regulatory Affairs Discussion Group, is a non-profit volunteer organization composed of Regulatory Affairs professionals from the Southern California area who are interested in participating in educational programs and networking with one another. Our membership includes individuals who work in Life Sciences industries such as medical devices, pharmaceuticals, biologics, IVD, dietary supplement, food and cosmetics.

OCRA has over 850 members representing more than 225 companies in Orange County and surrounding areas. Our members represent companies of all sizes and complexities.

OCRA meetings provide an educational forum and a means for the regulatory community to network. While our focus is regulatory in nature, our programs have also provided timely information for individuals involved in Engineering (software validation and product development), Marketing (advertising and labeling), Quality (Quality System Regulation), and other related fields.

Gift Bag Giveaways and Sponsorships Available
Contact Kimberly Syre at to inquire about sponsorship opportunities.

The 16th Annual FDA-OCRA Educational Conference
Applying Regulatory Science to the Marketing of FDA Regulated Products
June 12-13, 2013 at Irvine Marriott
For an Immediate Receipt, Please Use the On-Line or PayPal Option
$ 725 OCRA Members
$ 775 Non-members (includes OCRA membership for one year)
$ 475 FDA/Government/Students*

$ 425 OCRA Members
$ 475 Non-members (includes OCRA membership for one year)
$275 FDA/Government/Students*

* Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. The Student Rate does not apply to working professionals taking one or two courses on the side. Student ID and copy of current class schedule are required to register at this rate. Final eligibility determined by OCRA.

Log onto the OCRA website ( with your username and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member.

April 2nd, 2013

Continuous Improvement and Process Variations

 WEDNESDAY  April 17, 2013  
6 – 9 pm  

ASQ 702 San Gabriel Valley


Continuous Improvement and Process Variations

Presented by Tarek Elneil

Any manufacturing process has five components sequentially connected in the following order: Supplier, Input, Process, Output, and Customer; in short, called SIPOC. Each component of the process can affect the next one in order. The Supplier can cause a problem in process input, which in results can affect the Customer at the end of the chain. The six components of the process input interact with each other and cause process variations. The process variations can due to common causes or special causes. Continuous Improvement goals are to reduce the common causes and to eliminate the special causes. When the process is under control 99.7% of the product will be within its established specifications, or statistically within + 3 Sigma. Six Sigma and Lean Manufacturing are tools to reduce the process non-conformance due to common cause; it can reduce the process non-conformance from 1350 ppm to be 0.001 ppm. Root Cause Analysis and Kepner Tregoe are tools used to reduce the non-conformance due to special causes. The main objective of non-conformance investigation is to select effective solutions and prevent the problem from recurring.

About the Speaker Tarek Elneil

Tarek Elneil is a Quality Consultant with over 14 years of experience as a change agent for Continuous Quality Improvement in the biotech, pharmaceutical, medical device, and dietary supplement industry; with an extensive experience in problem solving and root cause analysis.

Throughout his career, he has improved the quality systems, reduced the non-conformances and deviation cycle time. He has trained employees on problem solving and root cause analysis, reducing 75% of the non-conformance average cycle time. Tarek has managed process improvement projects, and led CAPA cross-functional teams to investigate quality failures utilizing the Six Sigma tools.

As a Certified Manager of Quality and Organizational Excellence, he has been the guest speaker on Continuous Improvement and Root Cause Analysis at ASQ and APICS events in Southern California. Tarek is an expert in systems analysis and database management with an emphasis on statistical analysis and performance metrics.



  Biosense Webster

15715 Arrow Highway

Irwindale, Ca  


6 – 6:30 dinner/networking

6:30 – 8:30 meeting

8:30 – 9 Section business/raffles  


Subway Sandwiches, chips, cookie, drink

(Registration closes at noon on day of event to allow for ordering of dinner options)


Members $10-, Non-members $15, Students $10 –   


(.3 R.U.s Awarded)


To encourage interaction, seating is limited to the first 40 registrants, so sign up soon!  

For more information or special order, contact:   Event Coordinator – Jean Flores at 909-322-2011


Contact for questions:
Randy Canfield, ASQ 702 Chair at Randy Canfield
February 19th, 2013

PMBOK vs Six Sigma: Using their Body of Knowledge


Our Next Monthly ASQ 711 Seminar will be held on
February 20, 2013
6:30 PM

PMBOK vs Six Sigma
Using their Body of Knowledge Similarities Advantageously

By: Bill Trappan 

The two processes have many similarities and both are operated in accordance with detailed Bodies of Knowledge; BOK’s for Six Sigma from ASQ and Project Management from PMI.

The Project Management Institute (PMI), a 270,000 member organization, certifies project managers that have demonstrated, along with other requirements, satisfactory knowledge of the Body of Knowledge (PMBOK) for the profession.  Similarly, The American Society for Quality (ASQ), a 90,000 member organization, certifies Six Sigma Black Belt professional s that have demonstrated, along with other requirements, satisfactory knowledge of that Body of Knowledge.

Practitioners of both professions work diligently to implement the tools of their trade with the end goal of achieving the most expeditious, economical and quality completion of their project.    PMBOK major areas of their projects  are Initiation, Planning, Execution, Monitor and Control, and  Closure as contrasted to the more familiar (to Quality Professionals) DMAIC; Define, Measure, Analyze, Improve and Control. In both cases, project life spans are temporary, with the end result being a disbanding of the teams and their reassignment to other activities.

The presentation provides an overview of the relationship between the “tools of” PMBOK and the “tools of” Six Sigma and explains how this knowledge can be advantageous to project managers and/or Black Belts.


William H. (Bill) Trappen PE, until his retirement was the Director of Quality Assurance at Magnavox Electronic Systems Company, West Coast Division in Torrance, California; for the years 1980 to 1996.  His prior Project Management experience included Technical Program Manager – Installation of an integrated helicopter avionics system (IHAS) in CH-53A and CH-46A Helicopters; at Teledyne Systems Company; 1965 to 1969.  Technical Program/Project Manager – AN/ARC-50 Communication/Navigation System (A DOD classified system) at Magnavox; 1969 to 1980.  Use of project management methods as required by DoD contracts including full utilization of Network mapping using PERT and other tools of project management.

Bill now keeps busy as an independent Quality Management consultant and as an Adjunct Professor for the Master and Bachelor of Science in Quality Assurance Programs at California State University Dominguez Hills (CSUDH).  In this teaching position he has taught courses since 1992 in Quality Process Management, Quality Project Management, ISO 9000, Supplier Quality Assurance and Quality Metrics.  He has been on the Advisory Board for the MSQA and BSQA programs since 1987, serving as chair of the board from 2003 to 2006.  He also serves on the Advisory Board for The Registrar Company, a RAB certified ISO Registrar.

He has a BS Degree in Electrical Engineering from Oregon State University, an award in Manufacturing Operations and Production Management from UCLA, and a Master of Science Degree in Quality Assurance (MSQA) from (CSUDH). He is a Registered Professional Quality Engineer in the State of California, a Member of Epsilon Pi Tau International Honor Society and a Member of the Phi Kappa Phi Honor Society

Bill is a Fellow of the American Society for Quality (ASQ), past chairman of the L.A. Section (1987-1988) and past chairman of the Electronics Division (1992-93-94). He has held various other leadership positions in ASQ including serving on the National ASQ    Awards Board. He currently serves as a Deputy Regional Director for ASQ Region 7, ASQLA Education Chair, a member of the Awards and Recognition Committee and chairman of the Simon Collier Quality Award committee.

He is a certified Quality Manager, a certified Quality Engineer, a certified Reliability Engineer, a certified Quality Auditor, and a Fellow in the Institute for Advancement of Engineering. In 1991, Bill received the Simon Collier Award given annually by the Los Angeles Section to ASQ members that have provided outstanding contributions to their profession.  In 1995 he was awarded the Ralph Evans Award for his leadership in the Electronics Division.

As a member of the National Association of Industrial Technology, he served as Region 6 Director 1992-93, President 1993-94, and in 1994-95 as Past Chairman of the Industry Division. He was the Conference Chairman for the NAIT National Conference in Los Angeles in October 1996.

Please join us!  We are meeting at the:

HomeTown Buffet
Corona Hills Plaza
Corona, CA 92879
(951) 273-0573


6:30 PM:
Arrive & Have Dinner

7:00 PM:
Business & Program


February 9th, 2013

Introduction to Minitab


ASQ 702 is Proud to Present “An Intro to Minitab”

Date: Saturday, March 9th

Time: 8:00am – 1 pm

Location: Biosense Webster
15715 Arrow Hwy., Irwindale, Ca 91706
Are you new to Minitab, or perhaps just need a little help in maneuvering thru the menus? Want to learn more of the capabilities that this powerful program has to offer? This may just be the perfect class for you.

And, this class will be presented by two of Section 702’s popular trainers–Larry Bartkus and Dan Gonzalez.

Space is limited to 40 participants only, so register early to hold your spot.

Special Group Rate Option now Available!

Register at

Description about the Course:
We will walk through many of the most commonly used statistical applications for Quality work and data analysis. Topics covered will include Data Distribution, Sampling and Sample Sizes, Hypothesis Testing, Control Charts, Gage R&R, Capability Studies and perhaps a little Design of Experiments. Some actual examples will be demonstrated for the use of these tools. The step-by-step approach will be shown through the use of Minitab software. Many difficult topics will seem relatively easy by the end of this session.

Three or four Take-away:
– We will know what to do with large data sets.
– How to determine if data is normally distributed.
– How to graph and interpret results from an analysis.
– Which tool to use for applying statistics to a project or process.

About the Trainers:
Larry was named So Cal Biomedical Discussion Group’s Speaker of the year for 2007-2008 and 2008-2009 for his informative, interactive, and always humorous presentations. He is a Six Sigma Master Black Belt and Certified Quality Engineer with over 35 years in the Quality Profession. Larry has extensive experience having held positions such as Supplier Quality Program Manager for ev3, Master Black Belt for J & J, and currently as Distinguished Engineer at Edwards Lifesciences in Irvine, Ca. Larry is highly active in the quality community having volunteered as speaker for The Society of Plastic Engineers, the Society of Manufacturing Engineers, APICS, USC, and ASQ. He is frequently called upon to be an instructor for CQE Refresher courses and has conducted seminars on subjects such as Six Sigma/Lean, Process Control, Statistical Sampling, Design of Experiments, etc.

Dan Gonzalez is the Master Black Belt for Biosense Webster, a Johnson & Johnson company. He has over eighteen years of Industrial Engineering, Manufacturing Engineering, and Quality Engineering experience that span the Aerospace, Electronics, Medical Device, Service Consulting, and Sheet Metal industries. He holds degrees from Cal Poly San Luis Obispo, the University of La Verne, and is in the process of completing his Doctoral dissertation at Pepperdine University. Dan has been guest speaker for various subjects at ASQ, Pepperdine University, Cal Poly San Luis Obispo, Cal Poly Pomona, the University of Southern California, University of La Verne, and Cal State LA.


January 28th, 2013

Drug Shortages from the FDA, Industry, and Consumer Perspectives

Orange County Regulatory Affairs Discussion Group (OCRA)

 Friday, February 22, 2013

8:00 am to Noon

Free of Charge
OCRA Membership is Required

(Employees of Host Locations do not need to be Members)

Four Locations To Choose From:   

One Amgen Center Drive; Thousand Oaks, CA  91320

Beckman Coulter

250 South Kraemer Boulevard; Brea, CA 92821

 Bausch + Lomb

50 Technology Drive; Irvine, CA 92618


4939 Directors Place; San Diego, CA 92121

 (see below for driving directions to each location)


Program Managers:

Damon Jones, Vice President, Director of Operations, McGuff Pharmaceuticals, Inc.

 Tania Hoffman, MSRS, Sr. Regulatory Affairs Manager,  Spectrum Pharmaceuticals, Inc.

 Ruchika Raval, RAC, Principal, Global Biopharmaceutical Regulations, Inc.


Disruptions in the supply of potentially life-saving medications have become a critical public health issue. Many factors lead to prescription drug shortages.  Manufacturers are often unable to provide timely and complete information on the causes and potential resolution of these shortages to the public, which often leads pharmacies and healthcare facilities to try to find ways of avoiding negative outcomes in the patients they treat. In 2011, President Barack Obama signed an Executive Order directing the Food and Drug Administration to take on a greater role in reducing and preventing drug shortages. In 2012, Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, which lists the mandatory reporting requirements for manufacturers and provides FDA with important new authorities to help alleviate drug shortages. This program will look at drug shortages from the FDA, industry, and consumer perspectives and highlight efforts on all three fronts to manage this challenging issue.    


FDA Perspective 

Jeannie David, Program Management Officer, CDER Drug Shortage Program, FDA
(live from FDA Headquarters)

The speaker will discuss efforts underway at the FDA to address drug shortages, including interactions between the Agency and industry on manufacturing issues to maintain the safety and quality of medically necessary products while ensuring their continued availability.


Jeannie David, M.S. has been with the FDA since 2008. She is currently a Program Management Officer in the CDER Drug Shortage Program. She brings experience from her role as a Regulatory Health Project Manager in the CDER Office of New Drug Quality Assessment, the chemistry, manufacturing and controls (CMC) review division for new drug applications (NDAs), where she managed pre- and post-marketing applications, President’s Emergency Plan for AIDS Relief (PEPFAR) submissions, and presented a talk on Preparing for CMC Meetings with the FDA at the DIA 2012 Annual Meeting. Previously, Jeannie worked 7 years in the biopharmaceutical industry as a research scientist at Roche Palo Alto. She has a M.S. degree in neuroscience from the University of Wisconsin-Madison.  Ms. David will speak to us from Washington D.C.


Industry Perspective 

Scott McCarty, Risk Management Director, Amgen, Inc.
(Speaker will be at Amgen location) 

Scott McCarty has been with Amgen for 15 years, serving in a variety of roles in Operations and Quality Assurance. He is currently Director of Operations Risk Management, with responsibility for identification, characterization, and evaluation of risks to Amgen’s product supply chain. His prior Amgen experience includes leadership of a commercial product launch team and implementation of Amgen’s global change control system.

Prior to joining Amgen, Scott was a 20-year Navy fighter pilot, logging many aircraft carrier-based flight hours in F-4 and F-14 aircraft. Scott holds a bachelor’s degree in Economics from Stanford University, a master’s degree in Aeronautical Engineering from the Naval Postgraduate School, and the degree of Engineer in Aerospace Engineering from the University of Southern California.


Consumer Perspective

Speaker TBD
The speaker will discuss the effects of drug shortages on hospitals and patients.   


8:00 – 8:45 am

Registration and Security Check In

Continental Breakfast 


8:45 – Noon  

Speaker Presentations 



For Amgen, Beckman Coulter and Ardea employees, please email Rob Fleming ( with your name(s) and email addresses for each attendee.

All others please follow the instructions below. 



Be sure to log on and join or renew your OCRA Membership.  If you have not used our online system, you will need to create a new user profile before registering


Once you are logged on, click on “Register for a Meeting” on the right-hand side of the page. Next click on the meeting for which you would like to register, then follow the online instructions. You will receive an immediate confirmation.



Orange County Regulatory Affairs Discussion Group

5319 University Dr., Suite 641, Irvine, CA 92612

Tel:     949-387-9046

Fax:     949-266-8461 or 949-387-9047



OCRA’s non-profit Federal Tax ID# 33-0630455    






One Amgen Center Drive

Thousand Oaks, CA  91320


Note:  Please arrive at 8:00 am sharp as you need to be escorted to another building using Amgen’s shuttle.   


Please bring your photo ID for check in with Amgen security

Traveling Northbound on 405 and 101 Freeway

Take 405 Freeway North to 101 (Ventura) Freeway North.

Exit 47A Rancho Conejo Blvd.

Turn Right onto Ventu Park Road

Make a Left (before light at Pauling Dr.) into Building #37 parking lot.

Visitors to check in at Building #37 Lobby

Amgen Contact:  Amy Gonzales

Traveling Southbound on 101 Freeway

Traveling 101 S (towards Los Angeles)

Exit 47A, Borchard Rd. / Rancho Conejo Blvd.

Turn Left on Borchard Rd / Rancho Conejo Blvd

Continue to follow Rancho Conejo Blvd.

Turn Right on Ventu Park Road

Make a Left (before light at Pauling Dr.) into Building # 37 Parking Lot

Visitors to check in at Building #37 Lobby

Amgen Contact: Amy Gonzales

Beckman Coulter, Inc.

250 S. Kraemer Blvd.
Building #A
Brea, CA  92822

Directions from LA:
Take 405 S to 22 East.  Then take 57 N to Imperial Blvd.  Turn right onto  Imperial Blvd.  Go to the 5th Light and turn left onto Kraemer Blvd. Beckman Coulter will be on the right hand side.

Directions from San Diego:
Take 405 N to 55.  Then take 57 N to Imperial Blvd. Turn right at the end of the exit onto Imperial Blvd. Go to the 5th Light and turn left onto Kraemer Blvd.  Beckman Coulter will be on the right hand side.

Bausch + Lomb

50 Technology Drive

Irvine, CA 92618


From San Diego

Take 5 Freeway North

Exit at Alton Parkway (Exit 94B)

Turn Right onto Alton Parkway.

Take 1st Left  onto Technology Dr. W.

Bausch + Lomb will be on the Right.


From Long Beach

Take 405 Freeway South.

Exit at Irvine Center Drive (Exit 1C).

Turn Left onto Irvine Center Drive.

Turn Right onto Baranca Parkway.

Turn Left onto Technology Drive.

Bausch + Lomb will be on the Right.


4939 Directors Place

San Diego, CA 92121


From San Diego Airport

Take 5 Freeway North.
Exit at Sorrento Valley Road (Exit 30).
Turn Left onto Roselle St.
Take the 1st Right onto Sorrento Valley Road.
Take the 2nd Right onto Vista Sorrento Pkwy.
Turn Left onto Directors Place.
Ardea will be on the Right.

From Oceanside
Take 5 Freeway South to 805 Freeway South.
Exit at Mira Mesa Blvd (Exit 27).
Turn Left onto Sorrento Valley Road.
Turn Left onto Vista Sorrento Pkwy.
Turn Right onto Directors Place.
Ardea will be on the Right.

January 7th, 2013

Data Analysis: Making the right decision & proving it!

The Southern California Discussion Group of the ASQ Biomedical Division in association with ASQ SFV section 706 Presents:
Data Analysis: Making the right decision & proving it!

An Industry Roundtable Discussion
Tuesday, Jan 15, 2013 5:30pm to 8:30pm
Topic: Assessing data, making decisions, & presenting the evidence
We will walk through many of the most commonly used statistical applications for Quality work and data analysis. Topics covered will include Data Distribution, Sampling and Sample Sizes, Hypothesis Testing, Control Charts, Gage R&R, and Capability Studies. Actual examples will be demonstrated for the use of these tools. A step-by-step approach will be shown using Minitab statistical software so feel free to bring your computer preloaded with Minitab to work live examples if you so desire. Many difficult topics will seem relatively easy by the end of this session.

Know what to do with large data sets
Determine if data is normally distributed
Which tool to use for applying statistics to a project or process
Graph and interpret results from an analysis
Please bring your questions, experiences, and other commentary to make this a more valuable experience.

Expert: Larry Bartkus
Larry Bartkus has been named Speaker of the Year three times by ASQ Biomedical Southern California Discussion Group for his informative, interactive, and always humorous presentations. He is a Six Sigma Master Black Belt and ASQ Certified Quality Engineer with 40 years experience in the Quality Profession. Larry has extensive experience having held engineering and managerial positions in a variety of companies in the Biomedical industry including Master Black Belt for J&J, Supplier Quality Program Manager at ev3, and currently Distinguished Engineer at Edwards Life Sciences in Irvine, Ca. Larry is highly active and well known in the Quality Community having been Guest Speaker for The Society of Plastic Engineers, The Society of Manufacturing Engineers, APICS, ASQ, and 9 Colleges and Universities including USC. Larry is Past Chair for ASQ Section 702, San Gabriel Valley, and has served on their Executive Board for over 20 years. Larry is an Instructor for CQE, CQM, CQI Refresher Courses, and has conducted seminars on such topics as Six Sigma/Lean, Process Control, Statistical Sampling, Design of Experiments, etc. He has a wealth of knowledge to share with fellow Quality Professionals, both new and ‘seasoned’, and his open style of teaching and interacting with his audience makes the learning process enjoyable as well as highly effective.

Dinner & drinks will be provided.
Seating is limited to the first 40 registrants so sign up soon! Registration closes at noon event day.
Member Early Registration $20-
Non-member Early Registration $30-
Walkins $30- cash only if seating is available
Location: Baxter BioScience Auditorium, One Baxter Way, Westlake Village CA 91362

For more information Contact:
Dora Derashan (818) 693-6618 or email
As volunteers in a not-for-profit professional organization ASQ Biomedical, SCDG (Southern California Discussion Group) is committed to providing low cost high value events for biomedical professionals and the local community. We are able to keep our costs low by utilizing a registration system that incurs minimal administrative overhead expenses and minimizes excess time and effort spent by our volunteers to bring you these events. Please help us continue providing low cost quality programs to you by using the system that works well for us. If you do not wish to use the registration system to preregister, you may attempt to register at the event, however seating is limited therefore entrance and/or food cannot be guaranteed. Also, due to the nature of the low pricing scheme and the registration system used, we are unable to perform refunds.

November 6th, 2012

The Supplier Did What?!


All too often we realize (a bit too late) that for some reason suppliers have an impact on our products and services. As it turns out, ensuring the consistent supply of “good” parts and services is key to any business. But what should we do? And how far do we go before our process becomes too draconian? In this discussion we will go over some of the main elements any purchasing/supplier controls process should have as well as discuss some of the many ways these elements can be implemented.

Wednesday, November 14th , 2012 at 5:30pm
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop Valencia, CA 91355 from 5:30pm to 8:00pm

Come and meet Michael Holcomb, Principal Supplier Quality Engineer with Boston Scientific Neuromodulation. Michael has 22 years of experience working in Quality for the nutritional supplement, drug/biotechnology, and medical device industries. He has worked in nearly every area in Quality, which includes 8 years in Supplier Quality. In that time he has seen just about every way a supplier quality system can be (and in some cases, shouldn’t be) implemented. He earned a Bachelor’s degree in Chemistry from California State University, Northridge. He is a Senior Member of ASQ and is an ASQ-certified MQ/OE.

October 16th, 2012

The Difference Between Success and Failure in the Medical Device Business

Selecting Alternative Regulatory Pathways to Market


Orange County Regulatory Affairs Discussion Group

You are Invited to an Evening Meeting

The Difference Between Success and Failure in the Medical Device Business: Selecting Alternative Regulatory Pathways to Market


Wednesday, Oct. 24, 2012


6:00 pm – 8:00 pm  



Alcon Laboratories
15800 Alton Pkwy
Irvine CA 92618


Presented by:

Evan L. Rosenfeld, MD JD FCLM 

Vice President for Medical and Scientific Affairs

Theorem Clinical Research


Program Manager: 

Christopher Swanson, Regulatory Affairs Specialist 

Advanced Sterilization Products 


$50 OCRA Members 

$100 Non Members (includes OCRA Membership) 

$25 Students/Government
Free for Alcon Employees
(email Rob Fleming to be added to the list:  


Synopsis of the Session:

The choice and availability of a more attractive, alternative regulatory pathway to the U.S. marketplace often can make the difference between a medical device manufacturer’s financial and market success or failure. Thus, a medical device sponsor’s essential business viability – or lack thereof – can depend directly on both the existence and the successful use of such an unconventional approach to FDA, especially for young companies in their early stages of business development.

In a 1997 law, the “de novo downclassification process” was created to assist companies to bring to market their new, novel, and by definition “Class III,” medical devices by allowing clearance under the much less burdensome 510(k) regulatory route, instead of having to go down the difficult route of premarket approval (“PMA”). Ultimately, the ability to submit a far simpler 510(k) premarket application rather than having to go the PMA route can reduce time to market entry by several years and decrease up-front monetary costs by literally hundreds of thousands of dollars. The de novo process allows FDA to more quickly and more simply clear a new device for sale on the U.S. market despite the nonexistence of a predicate device to which the “new” device might be found substantially equivalent and, thus, which ordinarily requires a PMA. The de novo process instead only requires the manufacturer to develop and implement certain, far less expensive “special controls” that better guide the consumer (including physicians and/or patients) that are aimed at enhancing overall patient safety and minimizing potential device-related dangers to the public.

The current presentation includes a brief historical overview of the de novo process and its evolution to present day, provides a summary of companies that have used the de novo process successfully, outlines the timeline for this process, discusses the changes to the de novo process that have been implemented most recently, and analyzes the benefits to and the challenges still facing the medical device industry’s use of the de novo downclassification route for product regulation and ultimate entry to the U.S. market. Also to be discussed are the Agency’s recent parallel activities to – on its own initiative – downclassify several device types, as support for FDA’s real moves to assist device manufacturers to move their innovative products more expeditiously through the market clearance process and onto the U.S. sales market.

About the Speaker:

Evan L. Rosenfeld, MD JD FCLM

Vice President for Medical and Scientific Affairs

Theorem Clinical Research, Dallas TX 

Dr. Rosenfeld is in charge of leading the company in its efforts to assist clients with their complex strategic clinical study design, implementation, completion, and review/interpretation of such trial results, from the various perspectives of:
*  Optimizing regulatory pathways; Outcomes of governmental reviews for market clearance or approval; Post−clearance/approval market positioning (relative to potential and/or existing competitors); Long−term safety outcomes and assessments; and Overall scientific/clinical rigor of the clinical studies under advisement.

*  Involvement at all stages of clinical trials, ranging from first−in−man and feasibility studies (to confirm and support continued product development efforts) to post−market trials (e.g., to support reimbursement activities, ongoing safety and efficacy monitoring, etc.).

*  Involvement in all company business units, with predominant focus on medical device clients, including those with device−drug combination and in vitro diagnostic (IVD) products.

*  Providing senior oversight on large or complex ongoing projects to ensure quality, delivery and ongoing client satisfaction; Identify client needs and develop creative solutions for projects, leveraging expertise, operational capabilities and technologies.

* Maintaining a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner. * Building thought leadership by participating in conferences, events, and client presentations. * Leading client meetings, conduct capabilities presentations, and leverage personal networks and Business Unit expertise.

He has his MD from Medical College of Virginia, his JD from University of Pennsylvania Law School and a BA in Biology from Harvard.

 Click here to download the registration form 



For an immediate receipt and confirmation email, register on line at OCRA’s website,


If paying by personal or company check:

Please submit the online registration form. Mail your check made payable to OCRA to the following address:


Orange County Regulatory Affairs Discussion Group

5319 University Dr., Suite 641, Irvine, CA 92612

Tel:     949-387-9046

Fax:     949-266-8461 or 949-387-9047



OCRA’s non-profit Federal Tax ID# 33-0630455


NOTE: We will ask for a credit card payment for any checks not received by the meeting date

Cancellation Deadline:

For a refund, please cancel by replying to this email by October 17, 2012


If you have reserved a space but do not attend, your payment MUST be remitted.



Alcon Laboratories 

15800 Alton Pkwy 

Irvine CA 92618



It is recommended that you look up driving directions from your own starting point.  


Directions from LA:
Take I-405 S to Exit 3 (in Irvine).  Take ramp right and follow signs for Shady Cyn Dr/Sand Cyn Ave.  Turn left onto Sand Canyon Ave.  Turn right onto Alton Pkwy.  Go 0.9 miles and arrive at 15800 Alton Pkwy, Irvine.  The last intersection is Telemetry.  (If you reach Banting, you’ve gone too far.)

Directions from San Diego:
Take I-5 N to Exit 94B.  Take ramp right and look for signs for Alton Pkwy. Turn left onto Alton Pkwy.  Make a u-turn at Telemetry and arrive 15800 Alton Pkwy. (If you reach Banting, you’ve gone too far.) 


Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-387-9047
Alt Fax: 949-266-8461


August 23rd, 2012

How To Get It Right The First Time


ASQ FDC SCDG Presents…

How To Get It Right The First Time

Thursday, August 23, 2012

5:30 p.m. – 8:30 p.m.

Baxter BioScience

1 Baxter Way #100, Thousand Oaks, CA 91362

Speaker & Host:  Mary Thorsness, Quality Manager – CAPA Division, Baxter BioScience

Mary graduated with a bachelor’s in Biology from the University of California at San Diego. Mary has been  with Baxter since 2005 as BioScience Division CAPA Manager and is responsible for the division CAPA program in 15+ sites throughout the US and Europe. Among her responsibilities, Mary is a certified Lead Investigator trainer responsible for training potential CAPA owners, approvers, and other trainers.  Prior to her current position at Baxter, was had extensive leadership experience in the biotechnology and medical device industries.

Which Data Streams You Should be Analyzing and How: There are an overwhelming number of data streams that can be analyzed and reported on. How do you sort the “essential” and focus on them? Do these reported data streams stay the same through the years, or do they evolve as your industry, company, and regulatory climate evolves?

This interactive session will identify which data streams you should use to gauge the health of your products and quality system and how to measure and report them in a way that will be understood by those who review them.


 Identify which data streams you should use to gauge the health of your products

– Identify which data streams you should use to gauge the health of your Quality system

– How to measure and report that data in a way that will be understood by those who review it

Speakers:  Niedre Heckman, Manager – Regulatory Affairs, Baxter BioScience and Kumari Devulapalle, Chemist – 3M

Niedre Heckman is a Quality Management professional with nearly two decades of hands on expertise in quality assurance, quality control, regulatory affairs and research and development. She is a process oriented leader with diversity of experience across medical products. She couples experience in quality systems and regulatory compliance with business acumen to develop strategic solutions that achieve organizational goals.

Currently, Niedre works in Regulatory Affairs at Baxter Healthcare Corporation.  Prior to this, she worked for 3M in Quality and in Regulatory Affairs positions.

Niedre is involved with the professional organizations ASQ and RAPS, where she holds the CQA and RAC certificates, respectively.  Niedre has an MS in Chemistry from UC Irvine and an MPH from UCLA.

Dr.  Kumari Devulapalle, has extensive experience in biochemistry and biotechnology both in academics and biopharmaceutical industry over 20 years. She has contributed to different NIH grants on enzyme kinetics and protein modeling  during her work at University of Southern California before she moved to Amgen analytical R & D on method development and validation for therapeutic biomolecules.

  • She has been working for the past 8 years at 3M Northridge, in quality control aspects of the biopharmaceuticals where she is leading the implementation of Six Sigma Lean projects. She is also known in adapting Right The First Time, analytical method improvements for product testing and release.


The majority of drug products are not discretionary and are often urgently needed.  Depending on the type of product, for example biologics, shelf-life and storage factor into the urgency of getting products to the customer.  Thus, there is a business need and responsibility to provide high quality products in a reasonable, and sometimes expedited, manner.  This presentation considers best practices for getting drug products to the customer in two areas: (1) Product release of pharmaceuticals from the Quality Assurance Unit, and (2) Global product registration enabling world-wide product accessibility to customers.  This audience interactive session will provide some dashboard metrics used to ensure processes for efficiently getting product to customers are tracked for continuous improvement.  The session will also bring awareness to some of the interesting details that can slow down the process.


  • General understand of metrics than can be applied to product release and product global expansion
  • Tools that can be implemented in a high-volume quality control laboratory
  • Awareness of how US compliance issues can slow down or stop global expansion


5:30 pm – Registration and Networking

5:45 pm – Dinner

6:00 pm – Welcome and Introductions

6:15 pm – Speaker:  Mary Thorsness

7:00 pm – Break

7:15 pm – Speakers:  Niedre Heckman and Kumari Devulapalle

8:00 pm – Q & A

8:15 pm – Evaluation and Raffle Drawings

8:30 pm – Adjournment

** Dinner is included with your registration. Register now at 

July 13th, 2012

ASQ S706 50th Anniversary Celebration

August 10, 2012 at 6:00 PM – 9:00 PM

Rancho San Antonio, Chatsworth

~registration closed ~

Your ASQ Section turned the Big Five-Oh this year! That?s right, fifty, half a century. Come celebrate this auspicious occasion with your fellow members and friends. Walk down Memory Lane with the Board as we reminisce about things long past and not so long ago. Possibly an honored guest or two will surprise us. Feel free to bring your personal memorabilia for sharing stories from your era. If you know of a past member who might be interested but whose information is no longer available through ASQ Membership, please pass along this invitation so that they are not left out of the festivities. Contact Carole Elm (see above) if you have any questions. San Fernando Valley 706 was officially chartered as a section of American Society for Quality Control (ASQC) in May 1962.
Register today! ~registration closed ~
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