The Food Safety Modernization Act has introduced some of the most sweeping reforms to U.S. food safety laws in more than 70 years. It is mandated that all FDA regulated manufacturers in the United States and any foreign entity who produces food to be consumed within the US must comply to applicable final rules. This seminar offers a 360 degree view of food safety practices from a FSMA-centered approach. The courses will highlight the basics of food safety with an emphasis on compliance. The seminar will provide the tools needed to align your company’s governance, risk management, and compliance programs with new FDA regulations.
Why Should You Attend?
Attendees of the seminar are treated to a two-day deep-dive into the Food Safety Modernization Act and the relevant tools for compliance necessary to ensure your facility meets regulatory requirements. Participants will be trained on building a program that is resilient and agile in the fast-paced environment of food manufacturing and distribution. Sessions in the course will include understanding the basic elements of FSMA, building a framework of compliance using GRC capability tools, making the connection between HACCP and FSMA, and organizational improvement of documentation to ensure audit readiness. In addition, practical training segments will allow participants to learn how to identify and assess risks, calculate the applicable risk tolerances, and offer other tips and tools to apply risk management principles within an organization.
Learning Objectives:
- Understand the key concepts of the Food Safety Modernization Act and how it applies to various stakeholders within the industry
- Build an organization’s basic framework for compliance, utilizing GRC capability tools.
- Review and connect key concepts to FSMA including HACCP, Farm-to-Table, and Business Context Tools
- Understanding essential aspects of assuring compliance to current regulatory and audit standards for food safety
Areas Covered in the Seminar:
- Overview of the Food Safety Modernization Act
- A Framework to Address Compliance
- Hazard Analysis and Critical Control Points
- The Farm-to-Table Chain
- Accredited Third Party Certification
- Documentation and Audit Readiness
- Monitoring Changes to the Business Context
- Practical Tips and Tools for Applying the Training to Your Individual Organization
Who will Benefit:
- Senior leadership and management teams for FDA regulated food manufacturing, distributing, and transportation facilities, both US-based and abroad including:
- Quality Managers and Supervisors
- Regulatory Managers
- Food Safety Managers
- Production and Operations Personnel
- Sanitation Managers and Supervisors
- Warehouse and Transportation Leadership
- Compliance Professionals
- Risk Management
- Attorneys and Legal Staff
- Third Party Consultants servicing related facilities
Topic Background:
The FDA Food Safety Modernization Act (FSMA) grants sweeping new powers to the FDA that must be addressed an organization’s compliance program. FDA now has a legislative mandate that requires comprehensive, science-based preventive controls across the food supply industry. FSMA mandates that all processing facilities implement preventive controls that are appropriate for their operations. FDA has previously required HACCP (Hazard Analysis and Critical Control Points) for seafood and juice processors, as has USDA for meat and poultry, but FSMA makes HACCP-type preventive controls the norm in all food processing facilities. This new law is historic, because for the first time in more than 70 years, a significant overhaul of the statutory tool kit for combatting food-borne illness has been established. Organizations must understand how these changes affect the way they need to address compliance requirements around food safety.
- 08.30 AM - 09.00 AM: Registration
- 09:00AM – 11:15 AM – Understanding the Basics
- What is the Food Safety Modernization Act (09:00 – 09:30 AM)
- Business Context Leading to the Regulatory Change (09:30 AM – 10:00 AM)
- Morning Break (10:00 AM – 10:15 AM)
- FSMA Applicability (10:15 AM – 10:45 AM)
- BREAKOUT SESSION (10:45 AM – 11:15 AM)
- FSMA Case Studies: Students (or groups) are given a “company” in a specific industry and of a specific size; they must determine, based on what role the company plays in the supply chain what FSMA rules apply and what their compliance date(s) would be – facilitates deeper discussion on compliance dates and industry guidelines for various food sectors
- A Framework to Address Compliance - 11:15 AM – 2:30 PM (with lunch)
- What is OCEG? (11:15 AM – 11:45 AM)
- Lunch (11:45 AM – 12:45 PM)
- GRC Capability Framework (12:45 PM – 01:15 PM)
- Applying the GRC Capability Framework to An Organization’s Compliance Program (01:15 PM – 1:45 PM)
- BREAKOUT SESSION (01:45PM – 02:15 PM)
- GRC Assessment Tool: How to Use a Practical Threat Analysis – Students (or groups) are given access to a sample Practical Threat Analysis GRC tool with a specific scenario and are asked to build a sample analysis – facilitates discussion on GRC assessment tools and how they are useful in practical applications
- Afternoon Break (02:15 PM – 02:30 PM)
- What is OCEG? (11:15 AM – 11:45 AM)
- Hazard Analysis and Critical Control Points (02:30 PM – 04:30 PM)
- HACCP Basics (02:30 PM – 03:00 PM)
- How does HACCP Relate to FSMA (03:00 PM – 03:30 PM)
- A Proactive Approach (03:30 PM – 04:00 PM)
- BREAKOUT SESSION (04:00 PM – 04:30 PM)
- HACCP vs. HARPC Case Study: – Students (or groups) are provided a sample HACCP plan or HARPC plan and are asked to identify which it is based on the components contained within the example – facilitates discussion on the difference between HACCP and HARPC plans and the changing requirements due to FSMA
- END OF DAY ONE
- Farm-to-Table Concept (09:00 AM – 10:45 AM)
- What is the Farm to Table Concept? (09:00 AM – 09:30 AM)
- Following a food ingredient from farm to table (09:30 AM – 10:00 AM)
- Morning Break (10:00 AM – 10:15 AM)
- BREAKOUT SESSION (10:15 AM – 10:45 AM)
- Food Supply Chain Case Study: Students (or groups) are provided a food supply chain case study and are asked to identify as many issues as possible within the supply chain as the ingredient moves from farm to table – facilitates deeper discussion on farm to table and food supply chain issues
- Assurance 10:45 AM – 02:30 PM (with lunch)
- Internal Assurance (10:45 AM – 11:15 AM)
- Third Party Certifications (11:15 AM – 11:45 AM)
- Lunch (11:45 AM – 12:45 PM)
- Documentation (12:45 PM – 01:15 PM)
- Audit Readiness (01:15 PM – 01:45 PM)
- BREAKOUT SESSION (01:45 PM – 02:15 PM)
- Be the Auditor Case Study: Students (or groups) are provided pictures of and documents from food manufacturing and warehousing facilities and are asked to identify non-conformances – facilitates discussion on common industry issues within facilities and paperwork to hinder audit readiness
- Afternoon Break (02:15 PM – 02:30 PM)
- Applying Concepts to Your Organization. Monitoring Changes to the Business Context Tools on Implementation. (02:30 PM – 04:30 PM)
- Seven Key Business Context Tools (02:30 PM – 03:00 PM)
- How Business Context Tools Can Be Used for Implementation (03:00 PM – 03:30 PM)
- BREAKOUT SESSION (03:30 PM – 04:00 PM)
- Real World Problem Solving: Students (or groups) are asked to identify scenarios where business context tools are necessary for audit compliance, FSMA, and HACCP – ties together all concepts discussed at the seminar and recaps key learnings from each topic discussed
- Frequently Asked Questions / Q&A) (04:00 PM – 04:30 PM)
- END OF DAY TWO
Derrick Swint,
Owner and Principal Consultant, Zoetic Global Consulting
Derrick Swint's career has been shaped by his floor experience in the food manufacturing industry. Through the course of his career, he has worked several leadership roles in Sanitation, Pest Control, and Environmental Services. His many responsibilities have including coordinating programs such as developing and scheduling the Master Sanitation Program Schedule, SSOP development, scheduling sanitation in SAP, developing and scheduling housekeeping audits, internal audits, corrective/preventive action programming, and CIP administrator. Derrick has extensive years of bakery experience. He has been responsible for implementing many programs internally. Along with assisting with PCQI development, his food safety credentials include Certified Sanitarian, HACCP, Certified CIP Manager and Licensed Pest Control Operator and has additionally obtained certifications in BRC, SQF, and ISO 22000.
Miranda Peguese,
Principal Consultant, Zoetic Global Consulting
Miranda Peguese brings in-depth knowledge and rich experience to her role as a food safety consultant for Zoetic Global Consulting. Over the course of her career, she has worked in a variety of leadership roles in quality assurance, food safety, regulatory compliance, and sanitation. Her responsibilities have included coordinating programs such as HACCP, Statistical Process Control (SPC) GFSI certification SSOP development, supplier auditing, master sanitation scheduling, internal auditing, and corrective/preventive action programming.
During her tenure, Miranda, an experienced multi-site quality management professional has worked with companies in North America, South America, and Europe, assisting with the implementation and adherence of internal and external programs and standards. Miranda has worked with industries in the baked goods, dairy, frozen foods, fresh produce, beef processing, and food distribution sectors and maintains a number of food safety credentials including SQF Practitioner, Certified Retail Food Safety Manager, HACCP, SPC Certifications, and Six Sigma. She has most recently received certification in Advanced HACCP and PCQI.
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