FSMA Compliance Workshop, September 24, 2015

August 17th, 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.

Overview

FSMA is designed to insure food quality from the farm to fork. FSMA requires all food manufacturers to have written and enforced GMPs, Sanitation SOPs, Hygiene Training Manuals, a HACCP Plan, Recall Plan and to upgraded labeling. Yet profit margins are thin for most food manufacturing companies while competition remains strong. To further complicate matters the supply-chain is fragmented despite the efforts of many manufacturers to simplify their recipes and reduce exposure to possible allergenic foods. The FDA is taking a Preventive Controls stance emphasizing ‘self-regulation’ so that they can support companies through educating while regulating. The net result is that the FSMA law requires manufacturers to insure compliance not just for themselves but also for all their suppliers.

Who Should Attend

Two representatives from each company are highly suggested.

  1. CEO, CFO, or VP of Finance
  2. Head of Quality (job description)

In the past, we’ve found that the workshops were informative for participants but when they went back to their offices, they had an up-hill battle getting buy-in from the financial decision makers. Especially, if support from multiple departments is required to implement changes, as is so often the case when improving Quality systems.

Companies with both representatives get first priority in attending this limited space workshop. With representation from both Quality and Finance, we can work to overcome objections and get greater buy in right there at the workshop. FDA gains an understanding of the constraints (financial, operational, technical, talent) that companies are facing. In turn, all this helps QLN Leadership to craft the message for reaching corporate decision-makers across the country and set realistic expectations.

There are a number of reasons for your executive or financial leaders to attend. Quality reduces the risk of costly recalls. Quality reduces customer complaints. Quality tools can reduce operating costs by eliminating waste and refurbishing. Quality can improve brand value. This is an opportunity to have a conversation with FDA, the very people with enforcement authority, about both the benefits and constraints your company faces with respect to Quality. If they are unwilling to spend a half day attending, it is unlikely you would be likely to succeed in getting buy in after the event is over.

FSMA Workshop Agenda

Hosted by: LA District FDA
• Presentations by:
o CFSAN Food Supplier Verification
Program (FSVP.)
o NOAA.
o The State of California Food Drug
Branch.
• EDUCATE to help SELF REGULATE:
o FDA’s plan for implementing the
new FSMA law.
o What resources are available to
companies.
o What industries are in the
compliance priority list.
• Participate in real life case studies
about causes, effects and COSTS of
non-compliance.

What Do You Want To Do Next?

  1. Register for the FSMA Compliance Workshop, September 24, 2015
  2. Learn about the Quality Control Technician Apprentice Program
  3. Speak with someone about my staffing needs
  4. Learn about full-time recruiting services
  5. Submit my resume

How do I calculate the cost of complaints?

August 13th, 2015

Do you need to get a rough idea of how much customer complaints are hurting you?

Use this formula when talking to your Chief Financial Officer to measure the bottom line impact from the complaints you are receiving. Market Research has also published a decent page on how your complaints are just representing the tip of the iceberg.

Received complaints represent a small percent of loss. The example below shows how just 100 complaints on a product that costs $120 equals over $2 million in lost profit potential.

 

_______ Number of complaints

_/_.08__ Divide by 8%: average number that actually do complain – some estimates are as low as 4%

= _____ Total dissatisfied customers

x __24__ Average dissatisfied customer tells/influences 24 people, who probably won’t buy your product. Twenty four (24) seems to be the common number used on the internet, but none were backed up by citing an actual study. TARP was a common research outfit mentioned.

__ ___ Reach

x $____ Multiply by the price of product

=_____ Total lost revenues

-_____ Subtract the variable cost to produce your product

=_____ Lost contribution to margin

Example

How to calculate the cost of complaints

100 complaints on a product that costs $120 represents over $2 million in lost profits

This lost contribution margin can give you a rough idea of the potential budget for improving quality and handling customer complaints. It is only part of the total but it should get the conversation going with your CFO’s office. It’s difficult to put a dollar value on loss of brand value, potential punitive damages or the costs associated with regulatory warning letters (and the increased scrutiny that comes with them).

Apprentices Available

July 30th, 2015

Our Apprenticeships 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 Quality Technician apprentices working in the food industry and are working to place more in biotech, pharma and medical device industries. Available apprenticeships include Clinical Research Coordinators, Regulatory and Compliance and Quality Control with more to come. Learn more on our Apprentices page.

Risk Based Auditing and Fun-damentals

April 8th, 2015
You are Invited to an Evening Meeting

 

Risk-Based Auditing

and Fun-damentals

    

Orange County Regulatory Affairs Discussion Group

 

Tuesday, April 21, 2015
4:00 – 7:00 pm

 

Auditing is a part of life, almost irrespective of the industry.

We can make it as hard as we want, trading efficiency and effectiveness for a check box in the done column.

This program will provide an overview to a risk-based approach to the audit process plus an auditing process overview.

Location:   

Alcon Laboratories, Inc. – New Venue

15800 Alton Parkway
Irvine, California 92618

 

Program Manager and Speaker:  

James R. Lusk, Principal, Quality Systems International

About the Speaker

James (Rusty) Lusk has over 37 years of experience in regulated and non-regulated industries ranging from early-stage development to Fortune 100 companies. He has held senior management positions in disciplines such as Regulatory, Quality, Clinical Programs, and New Business Development. He is currently a Principal with Quality Systems International; a multidiscipline consulting company serving ISO/EN and FDA regulated industries. He is also co-founder of LifePulse, LLC, an early-stage medical device company and co-inventor of a non-invasive device intended to delay or reverse cardiovascular disease and improve quality of life.

 

He is Past President of Orange County Regulatory Affairs (OCRA) Discussion Group, a nonprofit organization with the mission of educating the regulatory professionals.

 

He has an MBA from Pepperdine University, a BS in Biological Sciences from The University of California, Irvine and an AA in Electronics from Orange Coast College.

 

He is has the following certifications: Regulatory Affairs Professional (RAC both US & EU), American Society for Quality: CMQ/OE, CQE, CQA, CQAHACCP and Lead Auditor, Quality Management Systems, RABQSA.

 

Schedule:

4:00 – 5:00 pm

Registration, Networking and Appetizers

 

5:00 – 7:00 pm

Presentation and Q&A

 

 

Cost:

OCRA Members: $50

Non Members: $100

*Students and Government: $25

     

 Click Here to Download the Event Flyer 

 

 

 

REGISTRATION INFORMATION 

Online Registration Instructions:

Step 1:   

Click on this link:

https://ocra-dg.org

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.

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

Email:  ksyre@cox.net

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.

The Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. This rate is not available for online registration. The Student Rate does not apply to working professionals taking one or two courses on the side. To qualify, please fax your registration form with student ID and copy of current class schedule to 949-266-8461. Final eligibility determined by OCRA.

RECEIPTS FOR PAYMENT Please use the online payment process for an immediate receipt.

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

Cancellations For a refund, please email your cancellation request to Rob Fleming (rob.fleming@yahoo.com) by April 14, 2015.

NOTE:  We will ask for a credit card payment for any checks not received by the meeting date. If you have reserved a space but do not attend, your payment MUST be remitted.

DRIVING DIRECTIONS       

Alcon Laboratories 

15800 Alton Pkwy 

Irvine CA 92618

 

 

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.)

 

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

 

  

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
Email:    ksyre@cox.net

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

OR

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 http://asqneconference2015.eventbrite.com

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 mmartin@asq.org no later than March 26, 2015.  Take advantage of this special NE Conference discount rate of $219.00 (regularly priced at $269/$419)!

REGISTER NOW!

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 http://fibr.info/programs/meet-your-inspectors/2015/index.html

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!

Details

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

Cost

FIBR, United AG, Sabor Latino, FCG,
Ca.Agribusiness CU, Vernon Chamber Commerce Members:
$35
Students: $25
Non-Members: $45

Cash or Check or online via PayPal

Payment

PAY ONLINE:

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

Registration

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: hmartinez@fibr.info

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

 

Registration: 

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 http://www.scifts.net/scfic.html

SCFIC 2015 promo flyer 2015-0107

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

November 17th, 2014

11/19/14 @ 6::00 PM

Location:

  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:

http://www.cvent.com/d/n4qy4w

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!

 

 About 

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.
Abstract

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!