Receiver Liability for Supplier Preventive Controls

Learn FSMA supply chain rules, supplier qualification, risk ranking, compliance duties, and how to manage supplier controls effectively.

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

Learning Objectives: -

 Understand the new supply-chain-applied control requirements

 Develop a system to collect appropriate supplier qualification and certification records

 Learn to risk rank your suppliers

 Eliminate low-scoring suppliers to prove your own supplier control system

 Learn to qualify suppliers, materials, equipment, and utilities

Areas Covered: -

 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

Background: -

The wait for the 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 potential 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.

Why Should You Attend: -

From the FDA FSMA rules, it is clear that 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.

Who Will Benefit: -

 Buyers at Food Distributors, Shippers, Processors, 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

Speaker Profile:

Dr. John Ryan is the president of RyanSystems.com and holds a Ph.D. in research and statistical methods. He has recently retired from his position as the administrator for the Hawaii State Department of Agriculture' s Quality Assurance Division, where he headed up Hawaii’s commodity inspection, food safety certification, and measurement standards service groups and piloted the nation’s first RFID farm-to-fork food traceability system. His latest books, “Validating Preventive Food Safety and Quality Controls”,” Food Fraud”, and “Guide to Food Safety During Transportation: Controls, Standards and Practices, 2nd Edition” are now offered by Amazon and Barnes & Noble. Dr. Ryan’s company (RyanSystems.com) helps to train and consult with companies in need of validating preventive food safety controls. For more than 25 years, he has implemented quality control systems for international corporations in the United States and around the world.

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What Attendees Are Saying:

In pharma, compliance is always top of mind, and this webinar really delivered. The strategies were practical, and I could immediately see how to apply them in our documentation work. - Rachel Morgan, Quality Assurance Specialist at a Biopharma Company

“WebinarWaves’ session was packed with insights we immediately applied in our facility. The speaker was fantastic and addressed real-world challenges.” – Samantha L., Director of Nursing, Skilled Nursing Facility

Seamless experience! The slides and handouts were clear and useful, and I was able to share them with our entire coding team.” – Brian K., Coding Supervisor, Hospital Network

Clear and informative session. Everything about compliance and regulations was explained in a way that actually makes sense. - Mei Lin, Regulatory Affairs Specialist

Valuable webinar! Provided valuable insight into how logistics risks are defined, managed, and communicated within the pharmaceutical sector. - Michael Torres, Supply Chain Manager