Validation Of Preventive Controls-Prepare Your Company to Meet The Final FSMA Rule Requirements for Preventive Controls for Human and Animal Foods.

Dr John Ryan

Starting at

$349


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The wait for final FSMA Rules is over. On September 10, 2015 the FDA published the final rules for the Preventive Controls for Human and Animal Foods. Being able to design, implement and validate preventive controls is probably the most critical aspect of all food safety programs and, by law, requires a specially trained individual to review your plan and implementation. Those certified in process validation will be able to maintain food safety while those who do not understand or cannot manage preventive control validation will be exposed to FDA enforcement. Large businesses have less than one year to fully implement the rules. 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 will present a practical approach to providing you and your team members with needed understanding and a basic strategy for designing, implementing and validating process controls. The FDA FSMA rules are based on the ideas that risk can be reduced through preventive approaches not widely understood or followed in the food industry. Regardless of your ability to understand or validate processes, process validation is now a legal requirement.

Course Objective

You must begin planning now. 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.

Learning objectives:
  • Understand preventive control validation.
  • Learn to use an integrated team approach.
  • Learn to use the lifecycle approach (continuous improvement)
  • Learn to control attributes and parameters.
  • Establish repeatability and reliability.
  • Learn to implement and use process experiments.
  • Learn to qualify suppliers, materials, equipment and utilities.


Course Outline

  • FDA FSMA Verification Requirements for Preventive Controls for Human Food.
  • Liability & Exemptions.
  • Building Preventive Control Knowledge and Understanding.
  • Strategy for Preventive Control:Qualification and Protocols.
  • Inputs, operating parameters, control limits.
  • Qualification of Process Performance (baseline data)
  • Establishing quality requirements and specifications.
  • The weaknesses of inspection and testing.
  • Statistical approaches and required data.
  • Material and equipment monitoring.
  • Process design and procedures.
  • Preventive Control Qualification.
  • Understanding and Controlling Variation.
  • Ongoing feedback about produce quality and process performance.


Target Audience

  • Food Shippers, Processors, 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.

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Dr John Ryan,

Dr. John Ryan is the president of RyanSystems.com and holds a Ph.D. in research and statistical methods. For more than 25 years, he has implemented quality control systems for international corporations in the United States and around the world. 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. His latest book published is “Guide to Food Safety During Transportation: Controls, Standards and Practices” is now offered by Elsevier Press who will also soon publish his newest book on “Food Fraud”. Dr. Ryan’s company, RyanSystems.com, trains and consults with companies needing to establish and maintain high-performance food safety and quality systems


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