Validating FDA FSMA Preventive Controls

Get control of your operation using the FDA FSMA Preventive Controls for Human and Animal Food Final Rules

This preventive controls session will thrust you and your staff into the world of hard quantitative data, what you need to collect, how to analyze it, and use it to drive prevention.  Verification activities are inadequate, and your team must make the transition to understanding and applying simple, relevant statistical and team management strategies.

Food distribution groups need to guarantee that their suppliers are all preventive controls qualified and certified. Regardless of your fear of “statistics,” many simple tools are available to support your transition into validation.

Learning Objectives:-

• Understand and control Process Design, Qualification, and Validation
• Know the difference between corrective action and prevention
• Identify Hazards and Adulterants
• Sampling, data collection, analysis
• Know how to work with cause and effect
• Identifying and controlling variation quantitatively
• Statistical Process Control (SPC) and other basic statistical tools
• Know how to establish and control a team approach
• Understand responsibilities regarding supplier qualification and certification
• Learn a simple and powerful technique to get your company quickly on track to compliance
• Develop the plan.

Areas Covered:-

• Understand and apply Preventive Controls
• Know the difference between Verification and Validation
• Leave validation in the dust (get on with life!)
• Work towards reducing reliance on costly inspections and audits
• Build work instructions and procedures
• Collecting and analyzing data
• Applying simple statistical tools and proving to management and yourself that you have control and are not just a victim of circumstances.
• Get true control of your operation.

Background:-

With the new FDA FSMA traceability rules coming into play, your ability to prevent food safety problems will put your company at the forefront for the world to see. Process verification (audits and inspections) is becoming a dead issue in light of validation requirements. You must be capable of proving that your food safety system is preventive and not just responsive.

Regardless of where you sit in the supply chain, you must protect your company by qualifying and certification of your suppliers to the preventive control requirements.

The wait for final FSMA Rules is over. The FDA published the 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, 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 rules.

Why Should You Attend?

Validation is where the food safety rubber meets the road.

According to the FDA, all food facilities must “monitor their controls, conduct validation activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions. This training session will present a practical approach to provide you and your team members with the needed understanding of “hard data” and a basic strategy for designing, implementing, and validating process controls. 

The FDA FSMA rules are based on the idea that risk can be reduced through preventive approaches not widely understood or followed in the food industry. Regardless of your ability to understand or verify processes, process validation is now a legal requirement. 

Food distribution groups need to guarantee that their suppliers are all preventive controls qualified and certified.

The clock has now started for the required implementation of all members of food supply chains for food to be consumed in the United States. The long wait for finalization and clarification of rule requirements is over.  Implementation deadlines are published, and most large companies have one year to fully implement and comply with these seemingly complicated requirements.

Who Will Benefit?

• Food Shippers, Processors, Retail, and Restaurant Purchasing Groups
• CEOs, VPs, and Director-level personnel
• Food Safety and Quality Team Members
• Food Testing Labs and Quality Personnel
• cGMP Specialists
• Operations personnel
• Food Process Engineers
• Audit and inspection personnel.