Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls

OVERVIEW:
Upon completing this course participants will leave with a preliminary preventive control implementation plan and will:

• Understand US FDA final rules for the Preventive Controls for Human and Animal Foods
• Define and review your current system to identify gaps in your preventive controls planning.
• Be able to develop and implement a valid preventive control company food safety plan to close any gaps
• Write and implement appropriate procedures.
• Know your requirements for control over your supply chain
• Be able to plan and implement HARPC
• Be able to perform environmental monitoring
• Know how cross contamination can impact your preventive control plan
• Know the difference between validation and verification
• Understand and be able to use statistical process controls basics
• Be able to plan and implement a team approach to preventive controls
• Be able to help your food importers to jump through FDA hoops
• Develop a system to risk rank your suppliers
• Have a plan in hand that will pass any validation check for preventive controls
• Understand some of the technology and costs that can help you establish preventive controls
• Prove that your system actually prevents food safety problems
• Be able to document and report results to upper management, external food safety auditors and FDA auditors
• Save your company money Establish simple, low cost complete data collection and reporting systems.
• Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system
• Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures
• Learn how to use your system to get some ROI and improve your marketing position
• Review current and future technologies designed to improve and simplify data collection
• Establish a completely documented system

Time: 9:00 AM to 6:00 PM

Why should you attend?

Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems, the plan is not considered valid and your overall food safety effort will fail audits.

According to the FDA all food facilities "must monitor their controls, conduct verification activities, provide hard data to validate that 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 needed understanding and tools and a basic strategy for designing, implementing and validating preventive process controls.

You will develop a basic plan during this training and have it checked by the instructor.
Regardless of your ability to understand or validate processes, process validation is now a legal requirement and you cannot wait for the FDA to develop their ability to assist your company

 

Areas Covered in the Session:

• Preventive Control System Planning Requirements and Goals
• Review of the FDA's FSMA Overall Rules
• Review of final rules for the preventive control of human and animal foods

               o Validation
               o Environmental Monitoring (Sampling/Test/Labs/Data)
               o Supply Chain Controls (Including imports)
               o cGMP

• Hazards and Adulteration
• Prevention versus Corrective Action
• Cross Contamination through Supply Chains
• Food Safety and Quality Planning (HARPC)
• Packaging
• Teams and Teamwork
• Continuous Improvement
• Measurement, Repeatability, Reliability, Calibration
• Statistical Process Control (SPC)
• Data, logs, forms and electronic record keeping
• Recall and Traceability
• Return on investment (ROI) and marketing advantages
• Integrated Food Safety Systems (Government vs Business needs)
• Transportation Processes
• Customers

Who Will Benefit:

• Mandatory for upper level management needing to understand impact of laws relating to food safety program validation
• Legal team members focused on food safety
• Food quality and safety personnel
• Food safety leads and implementation team members
• Maintenance operations personnel
• Food facility personnel
• Food importers whose food will be consumed in the U.S.
• Food security personnel
• Recall specialists
• Company sales and marketing personnel whose customers demand sanitary and temperature controlled distribution and transportation processes

AGENDA:
Day 1 Schedule:
Lecture 1:

• Preventive Control System Planning Requirements and Goals Preventive Control System Planning Requirements and Goals
• Review of the FDA's FSMA Overall Rules
• Review of final rules for the preventive control of human and animal foods
• Validation

Lecture 2:

• Environmental Monitoring (Sampling/Test/Labs/Data)
• Supply Chain Controls (including Imported Foods)
• c/GMP

Lecture 3:

• Hazards and Adulteration
• Prevention versus Corrective Action
• Cross Contamination through Supply Chains

Lecture 4:

• System Planning Activities

Day 2 Schedule:
Lecture 1:

• HARPC Food Safety and Quality Planning
• Packaging

Lecture 2:

• Teams, Teamwork and Continuous Improvement
• Measurement, repeatability, Reliability, Calibration
• Statistical Process Control

Lecture 3:

• Data, logs, forms and electronic record keeping
• Recall and Traceability
• ROI
• Integrated Food Safety Systems (Government versus Business)

Lecture 4:

• Transportation Processes
• Customers
• System Planning

Speaker:

John Ryan
President , TransCert , QualityInFoodSafety , RyanSystems

 

Dr. John Ryan holds a Ph.D. in research and statistical methods. He has spent over 25 years implementing preventive control systems for international corporations in Korea, Thailand, Malaysia, the Philippines, Singapore, Mexico and the United States. He was a graduate quality and operations management lecturer at Cal Poly in San Luis Obispo, California and has recently retired from his position as the administrator for the Hawaii State Department of Agriculture's Quality Assurance Division where he won awards for his visionary and pioneering work in traceability technology. He is now the president of Ryan Systems with websites at RyanSystems.com and the SanitaryColdChain.com.

 

His companies provide FSMA training in preventive food safety and quality and certify food transporters to sanitation and temperature control standards. He has published over 40 articles in quality systems and food safety. His latest books now available from Elsevier Press are entitled "Guide to Food Safety during Transportation: Controls, Standards and Practices" (2014) and "Food Fraud" (2015). He can be reached at [email protected].

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