August 1st, 2016

FSMA Compliance Workshop 2016

Thursday, September 22, 2016 from 7:00 AM to 2:30 PM (PDT)

Supplier Verification Plan of FSMA (Food Safety Modernization Act) & Supplier Risk Management, Controls and Audits

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.

Event Ended

Recap / Downloads / Presentations

Agenda FSMA Compliance Workshop 2016

Lewie Casey, ASQ FD&C Division
Dan Solis, Director, FDA Import Operations, Los Angeles District
Captain Larry Howell, Deputy Director FDA Import Operations Branch (FDA requests people visit their website on FSMA for the most up to date information)
Laurice Churchill, Chief Southwest Region of the NOAA Seafood Inspection Program
Mary Kate Miller, Regional Administrator Food Safety Inspection Unit of CDPH Food and Drug Branch (no slides)
Rosemarie Christopher, RxRS Apprentice Program for the Food Industry
Mas Hori, Consultant
Dick Sheppard, R&D Scientific
Scott Storms, FSNS

Overview

In an effort to ensure full transparency with the food, ingredient and food supplier industries, the FDA Los Angeles District Office is hosting a Regulatory Policy Lecture Series on how FDA goes about improving product, processes, and service quality through the use of quality tools. During cGMP investigations and through import inspections, FDA has noted several areas where industry could improve product quality. We will share our observations with food companies, ingredient companies, and suppliers to the food industry. The audience for these lectures includes professionals working in the food industry or with the food industry. These workshops will include presentations by the FDA SMEs and Food Industry SMEs discussing our current challenges with product quality and use of quality tools to address these quality issues.

This is the second lecture, part of a quarterly Lecture Series where FDA and Industry come together to provide regulatory guidance and Good Manufacturing Practice topics and case studies. Primary goal will be to explore methods to resolve these case studies. Registration is limited to FDA employees, Local Food, Ingredient, and Food Supplier Professionals. This facility can only accommodate 85 people.

You must register by September 15th to attend this event. No walk-ins will be allowed due to security requirements at this facility.

Future Discussion Group meetings will be open to other students and may be held at various locations to accommodate the convenience of the attendees.

Who Should Attend

Two representatives from each company are highly suggested to attend the FSMA Compliance Workshop 2016.

CEO, CFO, or VP of Finance
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.