AIB

Agenda

Agenda is subject to change. Please review our dress code.

Day 1

Time Activity
7:45 a.m. Registrations
8:00 a.m. Welcome, Introductions and Logistics
8:15 a.m. Why FSMA? 
Reasons for Change and 5 key elements of FSMA
9:30 a.m. FSMA Requirements Already in Place
  • Bi-annual Registration
  • Prior Notice
  • Violative Products
  • Access to Records
10:15 a.m. Break
10:30 a.m. Hazard Analysis and Risk Based Preventive Controls - HARPC (Part 1 of 4)
  • Overview
  • Subpart A: General Provisions
  • Subpart B: Current Good Manufacturing Practice
  • Part C: HARPC
12:30 p.m. Lunch (On your own)
1:30 p.m. Hazard Analysis and Risk-Based Preventive Controls (HARPC), Part 2 of 4
  • Part C: HARPC, continued:
    • Risk Assessments Raw Materials/Ingredients Process Steps
    • Hazard Analysis and Identification of Risk-Basked Preventive Controls
    • Environmental Risk Assessment 
    • Preventive Control Management Components
    • Managing Preventive Controls
    • Managing Verification and Corrective Actions
3:30 p.m. Break
3:45 p.m. Continue with HARPC, Part 2 of 4
5:00 p.m. Adjourn

Day 2

Time Activity
8:00 a.m. Hazard Analysis and Risk-Based Preventive Controls (HARPC), Part 3 of 4 
  • Part C: HARPC, continued: 
    • Environmental Monitoring is a Verification Activity
    • Product Testing is a Verification Activity
    • Preventive Controls Management Plans
    • Circumstances in which owner/operator is not required to implement a preventive control (Exemptions) 
    • Recall Plan
9:00 a.m. Hazard Analysis and Risk-Based Preventive Controls (HARPC), Part 4 of 4
  • Subpart D: Modified Requirements
  • Subpart E: Withdrawal of a Qualified Facility Exemption
  • Subpart F: Requirement Applying to Records That Must Be Established and Maintained 
  • Subpart G: Supply Chain Program 
  • HACCP and/or HARPC: Next Steps
10:00 a.m. Break
10:15 a.m. Continue with Hazard Analysis and Risk Based Preventive Controls (HARPC), Part 4 of 4
11:15 a.m. Foreign Supplier Verification Program (FSVP) 
  • Importance of Food Imports
  • Objectives of the FSVP
  • Definitions 
  • Requirements of the FSVP
  • Modified Requirements 
  • Consequences of Failing to Comply 
  • Challenges for 2015 and 2016
12:00 p.m. Lunch (On your own)
1:00 p.m. Continue with Foreign Supplier Verification Program (FSVP)
1:45 P.M. Sanitary Transportation
  • Goal of the Rule
  • Covered and Exempted Foods
  • Who Must Comply
  • Responsibilities of Shippers, Carriers and Receivers
  • Next Steps
2:30 p.m. Break
2:45 p.m. FDA's Plans for Implementing FSMA
3:25 p.m.  What Can We Do for a Successful Transition to FSMA? 
3:45 p.m. Course Evaluation and Post Test
5:00 p.m. Adjourn

Successful completion of this course earns the participant a certificate of completion and Continuing Education Units.

Learning objectives

  • List the primary pathogens that contribute to acquired foodborne illnesses, hospitalizations, and deaths in the US
  • Identify key reasons for an increase in product recalls in the US
    List the most common reasons for product recalls in the US
  • Identify some of the ways that consumers support food safety regulations
  • Identify the elements of the Food Safety Modernization Act (FSMA) that affect your organization
  • Recall the requirements related to bi-annual re-registration.
  • Recall the types of records the FDA can access, review, and copy under FSMA.
  • List one change to prior notice requirements resulting from FSMA.
  • List the additional information that responsible parties must provide to the FDA under the Reportable Food Registry rules.
  • Define key terms and concepts included in the General Provisions (Subpart A) of 21 CFR Part 117
  • Recall the purpose and use of FDA guidance documents
  • Evaluate potential hazards and identify preventive controls for known or reasonable foreseeable hazards associated raw materials, ingredients, process, and production environment
  • Identify the key hazard categories defined under HARPC
  • Identify the criteria used to design and conduct risk assessments
  • Identify Preventive Controls management components
  • Describe how to manage preventive controls, verification activities and corrective actions
  • Describe the reasons to conduct environmental monitoring and product testing 
  • Recall the components of an effective preventive controls management plan and apply them to a given food product
  • Explain under what circumstances a preventive control is not needed and how to manage such situations
  • Under the Preventive Control Rule, describe why you must have a recall plan
  • Explain when modified requirements to the Preventive Controls Rule apply
  • Identify the requirements for recordkeeping and retention
  • Identify conditions that warrant a supply chain control program
  • Identify the requirements of the supply chain controls, as applicable
  • Identify the key similarities and differences between HARPC and HACCP and how to reconcile the differences
  • Recall next steps for implementing HARPC and/or HACCP in your organization
  • Recall the purpose of the Foreign Supplier Verification Program (FSVP).
  • Identify the requirements of the FSVP for importers and their foreign suppliers.
  • Recall the consequences for failing to comply with the FSVP.
  • Recall the purpose of the Sanitary Transportation Rule (21 CFR 111) and foods that are exempted.
  • Identify entities that must comply with the Sanitary Transportation Rule and their specific responsibilities.
  • Identify recordkeeping requirements under the rule.
  • Recall the training requirements for those responsible for transporting food or product.
  • Recall the key elements of the FDA’s strategy and plans for implementing FSMA
  • Identify the changes to mindset, policies, programs, and procedures your organization must make to comply with FSMA

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