ASQ Northeast Conference 2015

March 4th, 2015

The FD&C Division and Princeton Section present…

 ASQ Northeast Conference 2015

Friday, April 10, 2015

7:30 a.m. – 5:00 p.m.

410 George Street, New Brunswick, NJ 08901

Are you ready to take the CPGP or CHA Certification Exam, but need a quick refresher course? Come join us at the ASQ Northeast Conference to take an intensive one-day review of the BOK and ask questions from certified professional(s).  Your trainer(s) will prepare you to sit for and pass the exam and help guide you through the test taking process.

Track A: CPGP Refresher Workshop


Track B: CHA Refresher Workshop

ASQ Member $160 (+Eventbrite fee)

Non-ASQ Member $185 (+Eventbrite fee)

Lunch and refreshments are included with your registration. Seating is limited to 30 people, so please register now at

Upon completing your registration to attend the conference, you will receive a special 30% off discount on a CPGP/CHA handbook and/or book of questions. Please take advantage of this special offer to help  you pass your exam.

Conference attendees also have the opportunity to take the certification examination for CPGP and CHA on Saturday, April 11, 2015 at 8:00 a.m. Attendees who wish to take the CPGP or CHA examination must complete the Examination Application Form and submit it with supporting documents and credit card payment to Mary Martin at no later than March 26, 2015.  Take advantage of this special NE Conference discount rate of $219.00 (regularly priced at $269/$419)!


FIBR: Meet Your Inspectors Forum

March 2nd, 2015

Wednesday, May 20, 2015

Embassy Suites (8425 Firestone Blvd., Downey, CA 90241)

8:00am Registration and Breakfast

9:00am Forum

  • Semonella Stanely Outbreak, State of California Department of Public Health
  • Did You Know?, CalOsha
  • FDA Food Safety Updates, FDA
  • Interactive Exercise with Local County Inspectors, Southern California Health Department
  • Allergens & Recalls and Safety Services (FSIS), USDA
  • Ask your Inspectors Panel

4:30pm Adjourn

For more information, go to

Register now!

FIBR Networking Dinner

February 2nd, 2015

2015 Chinese New Year Networking Dinner

Network with Food Industry Professionals from FIBR, United Ag, Sabor Latino, FCG,
Vernon Chamber of Commerce!


Thursday, February 26, 2015
5:30 p.m. to 8:30 p.m.

Empress Pavilion Restaurant
988 N. Hill Street
(located in the Bamboo Plaza-China Town)
Los Angeles, California 90012
TEL: (213) 617-9898

Click here for map and directions


FIBR, United AG, Sabor Latino, FCG,
Ca.Agribusiness CU, Vernon Chamber Commerce Members:
Students: $25
Non-Members: $45

Cash or Check or online via PayPal



Registration fee can be paid online via PayPal. Click here to pay and register online.

Pay by Check

If you prefer to pay by check, please make check payable to FIBR and mail to:
FIBR, 520 W. 23rd Street, L.A., CA 90007


IMPORTANT: Must RVSP online using the form below. Click here to pay and register online.

As This is a Food-included Event, Reservations are Considered Guaranteed.

Additional information: Email, Helene Martinez:

2015 Southern California Food Industry Conference

January 8th, 2015

Button Up for the Winds of Change 

Labels, Regulations, and Consumer Expectations


Wednesday March 4, 2015 9am – 3pm

Marriott Anaheim Convention Center


Come find out what’s on the horizon then head into Supplier’s Night at the same location


Consumer Perspectives Driving Nutritional and Regulatory Changes

Dr. Christine Bruhn, Director, Center for Consumer Research, Food Science & Technology, UC Davis


Regulatory challenges in the emerging food segment of cannabis edibles

Lisa Lupo, Editor, Quality Assurance and Food Safety Magazine


Background and impact of proposed changes to nutrition labels and serving sizes 

Martin Hahn, Lawyer and Partner at Hogan Lovells, Washington DC 


Insects as food, changing attitudes of the westernized “yuck” factor 

Dr. Florence Dunkel, Associate Professor, Montana State University


Food industry labeling outlook

Dr. Janet Collins, IFT Past President and Senior Manager, Regulatory Affairs, Dupont Company


Impact of the Food Safety Modernization ACT (FSMA) on the Food Industry

Stephanie Barnes, Regulatory Counsel, Food Marketing Institute


Continuing education credits applied for with IFT, AND, and ASQ



Student, Full Day: $45.00

Student, Half Day: $25.00

Non-Student, Full Day $95.00

Non-Student, Half Day: $50.00


Click her to register

SCFIC 2015 promo flyer 2015-0107

Continuous Improvement- An Approach Where, Why, How & What Matters?

November 17th, 2014

11/19/14 @ 6::00 PM


  Biosense Webster

15715 Arrow Highway

Irwindale, Ca


6 – 6:30 pm – Registration, Networking and Dinner


6:30 – pm – Welcome, Announcements and Introductions


6:45 pm – Speaker


8:15 pm – Q & A


8:30 pm – Evaluation and Raffle Drawings


8:45 pm – Adjournment


If you want a dinner selection, you must choose an option.

Follow this link to Register

Register Here
or copy and cut this link:

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!



Guneet Singh,

Sr. Director – Continuous Improvement, ADP – Added Value Services.


Guneet is a global business professional with continuous improvement experience managing
international strategic and functional units. He has designed and successfully launched continuous
improvement chapters in several companies in his professional carrier. Guneet has extensive work
experience in field of customer experience, continuous improvement in various industries across the
globe in companies like GE, Bank of America, SITEL & Stream Global services.

In the present day competitive landscape across industries, a new philosophy, methodology, or approach
evolves daily, inspires market infatuation, and gains organizational embrace to finally deliver results
which vary substantially and are often questionable. The result is a never ending race to complete
certifications and knowledge badges in order to establish standards that demonstrate proficiency in an
ever growing number of new approaches. This is where continuous improvement or business process
innovation takes a different path.
It is not about a badge or certification or standard; it’s about a mindset, an approach, a philosophy – to
continuously strive for excellence by challenging the status quo.
Make it the way you think, live, & operate


Guneet will share the approach ADP takes and how and what tools they deploy in addition to how they handle change

Fundamentals of Data Quality

November 17th, 2014

Wednesday, November 19, 2014

at 6:30 PM

Fundamentals of Data Quality
By: Michael Scofield,
Assistant Professor of Health Information Management
at Loma Linda University

When you are managing the quality of any process, the quality of the data also becomes important.  The data you use for monitoring should accurately and fairly represent the physical reality.  But how do you know?

This presentation reviews the fundamental principles of data quality, including presence of data (when it should be present), validity, reasonable-ness, accuracy, precision, and consistency.  Each of these are separate characteristics, and we will look at numerous vivid examples of data problems at the row, column, and file level.

We will also discuss how poorly-defined business processes (where humans are involved in data capture or data entry) contribute to inaccurate data.   Some data errors are impossible to correct if they describe an event that is lost in history.  Better to improve the data capture process through user-friendly (and understandable) screen design and business process design.

Bio: Michael Scofield is an Assistant Professor of Health Information Management at Loma Linda University.  He is a popular speaker, writer, and consultant in the fields of data management, data quality assessment, and data visualization.

His career has included education and private industry in areas of data quality, decision-support systems, data warehousing, and data management.  His articles appear in DM Review, the B-Eye Newsletter, InformationWeek magazine, the Northern California Oracle User Group Journal, the IBI Systems Journal, and other professional journals.  He has spoken to over 240 professional audiences in these disciplines all over the U.S., in London, and Australia.  He also has a variety of topics for general audiences.  These topics include satellite imagery, the succession to the British monarchy, and various travel topics.  He also has humor published in the L.A. Times and other journals.

We will meet at the:

HomeTown Buffet

When you arrive announce that you are with ASQ.

Reservations are not required & Spouses, Significant Persons and Guests are always welcome!

Please Join Us!

Outsourcing 101

October 17th, 2014
You are Invited to the Joint Fall Conference 

Outsourcing 101


Sponsored by

San Diego Regulatory Affairs Network (SDRAN)


Orange County Regulatory Affairs Discussion Group (OCRA) 


Wednesday, November 19, 2014 


Location:  Grand Pacific Palisades Resort & Hotel

5805 Armada Drive, Carlsbad, CA  92008 


Program Managers:

Amelia Cline, RAC, Regulatory Affairs Specialist, Peregrine Pharmaceuticals

Mugdha Dongre, Regulatory Affairs Specialist, Bausch and Lomb

Sybille Sauter, PhD, Associate Director, Halozyme Therapeutics, Inc.



As more and more companies abandon the concept of creating products solely using their own internal resources, effective outsourcing has become a key success factor in drug and device development. Driven by an increasingly competitive commercial environment, products need to be produced faster, cheaper, and must be available to a global market. While cost reduction is still the primary goal behind most outsourcing, improved quality and a shorter time-to-market are two additional benefits of partnering with specialized vendors. The relationship between the client company and these vendors creates new opportunities and challenges. The question: How can you best establish and nurture this relationship?


The OCRA-SDRAN “Outsourcing 101″ conference offers insight into current outsourcing trends and shares advice on vendor selection and vendor management. Industry experts will address topics such as choosing the right partner, relationship governance, legal aspects, and ensuring the quality of products globally. Additional two parallel panel sessions will focus on Pharmaceuticals/Biologics and Devices/IVD. During these roundtables with vendor representatives, you will have the opportunity to pose questions to the panel and receive helpful suggestions from some of the most experienced professionals in the business. Make sure you don’t miss this opportunity to join your colleagues in beautiful Carlsbad, CA at the Grand Pacific Palisades, share your own expertise, and learn from some of the best in our field.



7:30 – 8:15 Registration and Continental Breakfast
8:15 – 8:30 Opening Remarks: Regina O’Meara, OCRA President and IVD Regulatory Consultant
8:30 – 9:00 Keynote Speaker: tbd
9:00 – 9:45 Topic: Legal aspects of outsourcing

Speaker: Michael Swit, Special Council, FDA Law Practice, Duane Morris LLP

9:45 – 10:00 BREAK
10:00 – 10:50 Topic: Outsourcing for IVDs and Devices

Speaker: Natalie Kennel, President, NJK & Associates

11:00 – 11:50 Topic: Choosing the right toxicology CRO for your program

Speaker: Grace Furman, President/CEO, Paracelsus, Inc.

12:00 – 1:00 Lunch
1:00 – 1:30 Topic: Clinical trial conduct with CRO support

Speaker: tbd

1:35 – 2:05 Topic: Study data collection & verification

Speaker: Jamie Colgin, President, Colgin Consulting, Inc.

2:05 – 2:20 Introduction of panel sessions and chairs

Speaker: Regina O’Meara, OCRA President and IVD Regulatory Consultant

2:20 – 2:40 BREAK
2:40 – 4:10 Parallel Panel Sessions with Vendor Representatives: Discussion & Q&A

  • Drug/Biologics Panel (R. Lane, M. Paiz, chair: R. Hernandez)
  • IVD/Device Panel (A. Cotts, K. Kukulka, chair: N. Kennel)
4:15 – 4:30 Closing Remarks: SDRAN President-elect


Additional speakers and panelists to be added to the agenda. Periodic updates will be sent as new speakers are added. 




OCRA and SDRAN Members: $199

Government and Students: $100

Registration fee includes parking, breakfast, lunch, beverages and snacks. After the meeting, electronic access to the presentations will be made for all attendees. Dress code: Business casual 


 Click Here to Download the Event Flyer  






SDRAN Members:

Please register through SDRAN using this link:


OCRA Members:

Step 1: 

Click on this link:


Step 2:
Immediately log in 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. 


Step 3: 
Once you have logged on (and paid for membership) select the meeting you would like to attend and complete the registration process by filling in the appropriate fields.


If you are not a Member of either organization, we do require you to join either OCRA or SDRAN before registering for this meeting. 


To join OCRA go to this link:

To join SDRAN, go to this link:


PAYMENT OPTIONS To Pay With Credit Card 

Register and pay online as described above.  If you prefer to fax your registration form, please click on the form below to download it.  Complete the form and fax it with your credit card payment to: 949-266-8461

Click here to download the registration form

To Pay With Company or Personal Check

Please register online (see instructions above). Then select the “Pay Off-Line” payment method and select “Company Check” or “Personal Check”. Make sure to mail your check at least 10 days prior to the conference to ensure it is receive in time. Only paid attendees will be able to attend. If a check has not been received, you will be asked to provide a credit card as a hold until the check is received.

Mail your check payable to: 

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 

To Pay using PayPal

When registering online PayPal is one of the payment options.

PayPal requires that you set up an account with them prior to making payment for this meeting. Once you receive confirmation of your new account, then you can register for this meeting.

Please use the online payment process for an immediate receipt.

Name badges and materials will be provided at the on-site registration desk.

Registration Fee includes the following: Electronic access to available presentations, continental breakfast, lunch and parking.

Sorry, no cancellations available for this meeting.


Grand Pacific Palisades Resort & Hotel

5805 Armada Dr, Carlsbad, CA 92008
Reservations (800) 725-4723

Front Desk (760) 827-3200


From San Diego:

Take I-5 North to Palomar Airport Road in Carlsbad and turn Right.

Turn Left on Armada Drive and then Left again into Grand Pacific Palisades Resort & Hotel.



From Orange County or Los Angeles:

Take I-5 South to Palomar Airport Road in Carlsbad and turn Left.

Turn Left on Armada Drive and then Left again into Grand Pacific Palisades Resort & Hotel.



We recommend you look up driving directions from your own starting point.


Regulatory Inspections and How to Manage Them

October 17th, 2014

You are Invited to an Evening Meeting

Regulatory Inspections
and How to Manage Them   


Orange County Regulatory Affairs Discussion Group (OCRA) 


Wednesday, November 5, 2014 

5:30 – 9:00 pm 



HORIBA Medical, 9755 Research Drive, Irvine, CA 92618


Program Host: 

Azita Hedayati, MS, CMQ/OE, CQA, Director, Regulatory & Compliance, HORIBA Medical 


Program Manager and Speaker:

Gustavo Kobrin, President Strategic Regulatory Solutions, Inc.


Panel Manager- Kim Walker, MS, RAC (US & EU), Global RA & QA Consultant, Kim Walker Consulting

Trudy R, Papson, Principal Consultant, Regulatory Consultants Group and Former FDA Investigator

Deborah Madsen, PE, Madsen Quality and Regulatory Consulting and Former Notified Body Auditor


This program is intended to provide information on regulatory inspection types and how to manage them.

Regulatory agencies, such as the FDA, Notified Bodies and Registrars inspect industry to ensure conformity of your practices for the purpose of establishing compliance to applicable regulations. Regulated companies are inspected on a routine basis both domestically and on the international level. Some inspections are considered “for cause” if there are circumstances which require an unannounced inspection.


A company’s goal is to effectively manage an inspection and to reduce the impact on the company’s operations. The goal of the regulator is to ensure public health and safety. They are concerned with enforcing and obtaining voluntary compliance with laws and regulations, protecting consumers from products that are impure, harmful, ineffective, improperly labeled, or in some other way dangerous, defective or deceptive.


Please join us in an informative and practical forum as we discuss how to manage an inspection, FDA-483s, Warning Letters and Notified Body Reports. We will also cover NCR best practices and how to manage them. Hear from an expert panel in regard to true war stories and how they were managed and resolved.




No on-site or walk-in registrations will be accepted for this program.

Space is limited at this facility and registrations will be accepted on a first-come-first-serve basis.



5:30 pm Registration, Networking and Dinner

6:00 pm Program Opening

6:05 pm Inspection Processes, Preparation and Management

6:30 pm Managing resolution of inspection findings and other post-audit activities

7:00 pm Break

7:10 pm Case Studies and Panel Discussion

8:30 pm Q&A

9:00 pm Adjourn

Speaker/Panelist Bios:  

Gustavo “Gus” Kobrin, President of Strategic Regulatory Solutions, Inc. (SRS)

Gustavo Kobrin has been a quality assurance and regulatory compliance consultant since 1998. His company, Strategic Regulatory Solutions, Inc., specializes in international and domestic regulatory affairs, regulatory compliance including product registrations, regulatory inspection management, quality system development, auditing, and project management.

Gus is a Notified Body Auditor (ISO9001:08, EN ISO13485:12, CMDCAS and MDD (93/42/EC)), Certified Quality Auditor (CQA) and Certified Regulatory Affairs professional (RAC) with more than 35 years of experience in the medical device industry. Mr. Kobrin has assisted numerous medical device companies, from the very small to multi-national corporations. He is a long time member of ASQ and RAPS. He has served on the OCRA Program Committee and on its Board of Directors. Kobrin holds a Bachelor of Science degree from the University of California, Irvine.

Deborah Madsen, PE, Quality Systems and Regulatory Compliance Consultant 

Deborah has been working in the medical device and in-vitro diagnostic industries for over 28 years. Deborah as held several roles at UL (a Notified Body) including regional lead reviewer, lead auditor, instructor/trainer, auditor qualifier, technical support for medical regulatory sales, and technical file assessor. She served as regional lead reviewer with responsibility for reviewing audits performed by other staff members and making certification decisions as well as determining whether companies were eligible for registration. She conducted audits as lead auditor in accordance with ISO 9001, ISO 13485, implementation of HC CMDR requirements under CMDCAS program, Medical Device Directive (93/42/EC), In Vitro Diagnostic Directive (98/79/EC), ISO 14971, and IEC 62304.


Prior to her work at UL, she spent eight years at a leading manufacturer of in vitro diagnostic and laboratory equipment, where she was responsible for worldwide product safety, EMC compliance, quality systems and regulatory compliance. Deborah also served as standards developer, U.S. technical expert, and member of IEC TC66 (laboratory equipment, IEC 61010-1) and contributed to development and revision of IEC 61010-1. Served as convener for IEC TC66 WG10 (centrifuges) and TC 66 WG11 (in vitro diagnostic equipment). Led development and issuance of IEC 61010-2-020, IEC 61010-2-089, and IEC 61010-2-101.

Deborah holds a degree in electrical engineering from the University of Illinois – Urbana and is a Registered Professional Engineer.

T.R. “Trudy” Papson, Principal Consultant, Regulatory Consultants Group

Trudy Papson is co-founder of Regulatory Consultants Group (RCG) and former FDA Investigator with the U.S. FDA, Los Angeles District Office.In her career at the FDA, she conducted hundreds of high profile, compliance follow-up and for-cause medical device inspections. Her experience also includes conducting pre-approval inspections, medical device pre-market/post-market approval inspections and BIMO inspections of clinical investigators and sponsor/monitors.


She received the Department of Health Services highest awards as a Medical Device Investigator. As Recall Coordinator she oversaw and worked with industry on serious public health threats and related problems with international significance. Papson is the recipient of numerous awards by the FDA for service and excellence.


Kim Walker, MS, RAC (US & EU)

Kim Walker, MS, RAC is an independent Global Regulatory Affairs and Quality Assurance Consultant and an owner of Kim Walker Consulting since 2006. In her consulting practice, she assists clients with pre- and post-market regulatory and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.

Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. Additionally, she served on the OCRA Board of Directors 2004-2010 and was the 2008-2009 President. Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3. Quality Management System: Continual Improvement. She has managed, presented at and/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics. She also has participated in the SDRAN Mentoring Program since 2009. Kim participated on the CSUPERB Advisory Committee and Development Team for the Project Management in Clinical Trials certificate program through the California State University system. She was the instructor for the “Pre-Market Submission” course and co-instructor for the “Regulatory Requirements for Medical Products” course in the certificate program. Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at the University of California Irvine Extension. She achieved both the US and EU RAPS Regulatory Affairs Certifications. Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development.

She graduated from Auburn University with a Bachelor of Science degree in Bio-Medical Sciences and graduated with a Master of Science degree in Regulatory Affairs from San Diego State University.




OCRA Members: $50

Non Members: $100 (includes OCRA Membership for one year)

Government and Students: $25

FREE for HORIBA Employees (please email Azita to be added to the list)



Registration fee includes light dinner, beverages and parking.


After the meeting, electronic access to any approved presentations will be made for all attendees.  


Dress code is business casual.



Click Here to Download the Event Flyer

Precision Medicine: A Medical Miracle or Ethical Nightmare?

October 17th, 2014

Date(s):                Nov 6 2014, 05:00 PM to 07:00 PM

Location:               CareFusion Corporation


During this presentation you will explore the concept of precision medicine and how it impacts the conduct of oncology clinical trials, regulatory guidance, subject recruitment, and the protection of human subjects participating in research. Learn to recognize the therapeutic misconception and how it impacts patient, caregiver and investigator/physician in the decision-making process. We will debate the concept of “hope” and “autonomy” and how it impacts patient/caregiver decisions regarding clinical trials when research subject is facing a life-threatening disease.

Travel Information


Cancellation Policy

The Reproducibility Crisis in Biomedical Research

October 17th, 2014


The Reproducibility Crisis in Biomedical Research

An ASQ Los Angeles Section and FD&C Division Joint Event


Wednesday, October 29, 2014
5:30 p.m. at Phenomenex
2341 West 205th Street, Torrance, CA 90501



New quality practices developed by the ASQ FD&C Division could change the trend in the reproductibility crisis in biomedical research!

“The productivity of modern drug development has been steadily declining over the last two decades. The total spend on biomedical research has reached about $270 million globally, but the number of new drugs relative to this investment has been going down steadily. There are many reasons for the declining output of drug development, but one of the main reasons is the lack of reproducibility of biomedical research in general. Some people even claim that the majority of biomedical studies cannot be reproduced. There is now mounting evidence that general quality problems are a root cause for this issue. Indeed, there is no commonly accepted quality standard for biomedical research. A working group of the ASQ FD&C has therefore developed new guidelines for “Best quality practices for biomedical research in drug development” which will be discussed in this session.”

Ülo Palm, MD, PhD, MBA, is currently Senior Vice President Branded Drug Development Operations with Actavis Pharmaceuticals. Prior to Actavis, he was the SVP Clinical Operations & Biometrics and Therapeutic Area Head Respiratory Clinical Development with Forest Labs. Before joining Forest, Dr. Palm held the positions of Global Head Laboratory & Preclinical Quality Assurance and Global Head Clinical Operations Oncology with Novartis Pharmaceuticals. Prior to Novartis, Dr. Palm worked with Schering-Plough and Bayer in different operational and medical drug development functions. He has a total of 25 years of experience in the pharmaceutical industry. Dr. Palm is Senior Member of the American Society for Quality (ASQ), he is certified as a Manager of Quality and Organizational Excellence (CMQ/OE). He serves on the Board of Directors of ANAB, the ANSI-ASQ National Accreditation Board. He is also a member of the TransCelerate BioPharma Operations Committee and chair of the Future Initiatives sub-committee, investigating new project opportunities for TransCelerate to improve the efficiency of clinical research.