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

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

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