Complying With New FDA FSMA Preventive Control Rules: Planning Valid Preventive Food Safety Controls Seminar

Global Compliance Seminars

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 and product controls.

Course Description

Course "Complying With New FDA FSMA Preventive Control Rules: Planning Valid Preventive Food Safety Controls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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
- Leave the training with your company PCQI approved preventive control and food defense plans
- Define and review your current system to identify gaps in your preventive controls planning.
- Learn to close any gaps
- Identify any needed procedures
- Know your requirements for control over your supply chain
- Be able to plan and implement Preventive Controls
- 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
- Be able to 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 team building between food safety and quality personnel to develop and implement changes to your current system
- Establish a completely documented system
Why should you attend:

Planning, implementing, verifying and validating preventive food safety controls is where the rubber meets the road in terms of prevention. You and your team can come to this training to collectively develop the food safety plan and defense plans, learn to implement the plan, verify plan implementation, and prove that you are actually preventing food safety problems.

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 and product 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
- Compliance 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:

Dr. 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 "Validating Preventive Food Safety and Quality Controls" (2017), "Guide to Food Safety during Transportation: Controls, Standards and Practices, 2nd Ed." (2017) and "Food Fraud" (2015). He can be reached at jryan@ryansystems.com.

Credits Available

More Seminar Information

Global Compliance Panel
Summary	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 and product controls.
Delivery Method	Seminar
Who Should Attend	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, Compliance 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