FDA FSMA Avoiding Criminal Consequences

(Webinar length:  1hr 56min)


The newly finalized FDA FSMA Preventive Controls will require that all registered food supply entities establish what the FDA call “valid” preventive control plans.  Under FSMA, a food company executive, manager or employee can now be charged with a crime even if they did not know they were selling product that was contaminated or making people sick. 

If you cannot or do not work to establish valid preventive controls through analysis of data and causes, your company is open to new FDA and Department of Justice (DOJ) enforcement activities.  The FDA and the DOJ are currently working diligently to drive these new legal food safety requirements through the prosecution of company personnel who do not comply with preventive control rules.  Their current prosecution efforts are focused on companies not in compliance if the company has caused a recall, illness or death and regardless of whether or not the company has intentionally avoided compliance.

Validation of your company preventive control plan means that your company and your suppliers must prove that you can control hazards or are working to control hazards.  This means you must establish systems to implement environmental sampling and preventive controls and be able to use the data from your processes and these samples to continuously improve food safety.  The data that is returned to you from the samples and other monitoring activities will provide you with baseline and ongoing monitoring information regarding how preventive your processes currently are and how to correct those that are not preventive.

The data from the labs and other process data must be statistically analyzed, causes identified and procedural and process changes implemented to continually improve your internal operations.  This is a giant leap in requirements from what we all have known as last year’s “food safety audit”. Quantitative evidence and objective analysis are replacing older strategies that were basically reviews of your ability to document activities as part of your verification requirements.

If you are afraid of “statistics”, this easy introduction will make enough sense for you to begin developing a sophisticated strategy to attack causes of chemical, bacterial and physical hazards.

This 2-Hour webinar is a “how to” training that goes far beyond “what you need to do” training.  You will learn to define problem areas, analyze causes, establish a systematic approach to improvement and document your efforts.  You will learn basic statistical concepts, how to apply them in everyday settings and learn the difference between problems caused by your company’s system and problems that are assignable and attackable by process teams.

This webinar will help you understand and be able to use:

  • Common and assignable causes
  • Assigning teams to system causes and assignable causes
  • Solution Tracking Sheets (STS)
  • Basic Mean and Range charts
  • Control limits
  • Use statistics to make decisions
  • P-charts
  • The meaning of six-sigma
  • Easy to understand decision making rules

What you will learn:

  • Quickly and easily learn the SPC language
  • Establish an SPC monitoring system
  • Collect Data
  • Perform simple calculations
  • Quickly calculate basic process averages and ranges
  • Interpret SPC Trends
  • Know when to make changes and when to leave things alone
  • Understand the difference between common and assignable causes
  • Set up basic Mean, Range and p-charts
  • Understand control limits and the place they play in decision making

Who will benefit from this webinar:

  • Mid-level personnel from all registered food operations
  • Food safety team members
  • Food quality personnel
  • Managers and supervisors in food operations
  • Sanitation specialists and teams
  • Personnel working on preventive control plans or teams

Presenter—Dr. John Ryan:

Dr. John Ryan holds a Ph.D. in research and statistical methods. He is President of the Sanitary Cold Chain which provides food safety assessment, training, audit and certification services to shippers, carriers and receivers impacted by the new law. He is 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.  He also spent two years as a co-team leader for President Obama’s FDA/CDC Information Technology team and  served on the FDA Performance Management and Standards Developments teams.

His latest book “Guide to Food Safety During Transportation: Controls, Standards and Practices” was recently published.

  • Item #: 0721gFDA
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Price $289.00