Description :-

Based on the FDA FSMA rules for preventive controls and their emphasis on planning for and implementing preventive systems, the final rules require that food supply chain members understand new supply-chain-applied control requirements.  These requirements mean that food and food ingredient buyers must develop a system to collect appropriate supplier qualification and certification records as part of their approval of suppliers system.

Generally, this data repository should be used to risk-rank suppliers for several reasons.  First high risk suppliers (those with inadequate preventive systems) should be educated and motivated to improve their own preventive controls.  Second, high risk suppliers are generally those who, in the event of a recall, are primary candidates for investigations.  Such systems mean that the supply chain controls and data can be used to reduce the time to recall impacted products and to prevent the spread of illness and prevent death.

The system should be used to eliminate low ranking suppliers, materials they use as well as the facilities and training employed to deliver goods.

Why should you attend?

From the rules, it is clear that the under FSMA, the FDA is making receivers liable for supplier preventive control programs.  Only suppliers clearly approved and qualified by you may now supply foods and ingredients to your operation.  Supplier established hazard preventive controls have now become your hazard preventive controls. 

Background of the topic: 

The wait for final FSMA Rules is over.  In September, 2015 the FDA published the final FSMA rules for the Preventive Controls for Human and Animal Foods.  The newly published Subpart G rules for “requirements to establish and implement a supply chain program” clearly establish receiver liabilities focused on preventing the potential of supply chain hazards from entering the food supply chain.  New rule requirements include 33 different sections intended to establish what food receivers “must” do to comply. 

Both U.S and imported foods are covered.  In the rules, receiver responsibilities for verifying the validity, implementation and documentation of hazard reducing supply-chain-applied controls means that receivers must select, qualify, certify verify and manage suppliers they use.

These new Subpart G rules recognize inherent need for receivers to assure that the food they receive and process are not only the responsibility of the supplier but, now, make the receiver liable for supplier preventive controls as well.

In this session, we will lay out these new supply-chain-applied control rule requirements and explore some of the options open to receivers when it comes to assuring that their own documentation systems provide proof of rule compliance.

Areas Covered in the Session:

• FDA FSMA Subpart G requirements to establish and implement a supply-chain program
• Liability
• Responsibilities of the receiving facility
• Using approved suppliers
• Conducting supplier verification activities for raw materials and other ingredients
• Onsight audits
• Records requirements

Who will benefit:

• Buyers at Food Distributor, Shipper, Processor, Retail and Restaurant Operations
• CEOs, VP and Director Level Personnel
• Food Safety and Quality Team Members
• Food Testing labs
• Quality Personnel
• cGMP Specialists
• Operations and legal personnel
• Recall teams
• Marketing and Sales Personnel