Validation of Process Controls: Prepare to Meet the Final FSMA Rule Requirements for Human Foods

Using Validation of Process Controls to Meet New FSMA Rule Requirements

The wait for the final FSMA Rules is over. On September 10, 2015 the FDA published their final rules for the Preventive Controls for Human and Animal Foods. Being able to design, implement and validate preventive process controls is probably the most critical aspect of all food safety programs. Those capable of process validation will be able to maintain food safety compliance while those who do not understand or cannot manage process validation will be exposed to FDA enforcement. Large businesses have less than one year to fully implement the new rules.

Validation is where the food safety rubber meets the road!

The FDA FSMA rules are based on the concept that risk can be reduced through specific preventive approaches—many of which are not yet widely understood or followed in the food industry. These approaches target processes as well as control points. Regardless of your conceptual understanding of the new system, process validation is now a legal requirement, so a strategy towards implementing it is key.

According to the FDA all food facilities must “monitor their controls, conduct verification activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions.” This training session with Dr John Ryan will present a practical approach to provide you and your team with insight into the new rules and a basic strategy for designing, implementing and validating process controls. 

The long wait for finalization and clarification of rule requirements is over, and the clock is ticking for all members of the food supply chain in the US. Implementation are out and most large companies have one year to fully implement and comply with these new, seemingly arcane requirements. Don’t let your company be caught off guard—get on top of process validation now so you can implement it on time.

Session Highlights:

• Understand preventive controls
• Review the concepts of verification versus validation, and how they apply to the new rules
• Build work instructions and procedures for implementation
• Understand the flow of process design, qualification and validation under the new rules
• Learn the difference between corrective action and prevention
• Identify potential hazards and adulterants
• Plan out the necessary sampling, data collection,  and analysis
• Know how to work with cause and effect
• Learn how to identify and control variation quantitatively
• Understand Statistical Process Control (SPC)
• Know how to establish and control a team approach
• Review responsibilities regarding supplier qualification and certification

Who Should Attend

• Food shippers
• Food processors
• Food retail and restaurant purchasing groups
• CEOs, VP and director level personnel
• Food safety and quality team members
• Food testing labs and quality personnel
• cGMP specialists
• Operations personnel
• Food process engineers

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