FDA FSMA Rules 2017 - FDA FSMA Rules & Planning Valid Preventive Food Safety Controls 2017

Course "Preparing to Comply with the New FDA FSMA 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
• 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
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's quality system career has spanned the manufacturing, food, transportation and Internet industries over the past 30 years. He has worked and lived extensively throughout Asia and the U.S. at the corporate and facility levels for large and small companies as a turn-around specialist. His clients have included Seagate Technology, Read-Rite, Destron IDI, Intel, and GSS-Array. He has consulted, taught at the university graduate level, and is a retired quality assurance administrator from the Hawaii State Department of Agriculture. He holds a Ph.D. and has been involved in the quality profession for over 30 years on an international basis and in a variety of industries. He designed and piloted the United States first RFID enabled farm to retail traceability system in the nation while working with Motorola, Lowry Systems and other well-known industry companies. He has published over forty papers on quality systems and has recently published a book for Elsevier Press entitled "Guide to Food Safety and Quality During Transportation: Controls, Standards and Practices". He previously published "The Quality Team Concept in Total Quality Control" with the American Society for Quality. He began Ryan Systems over ten years ago.
Ryan Systems works with some of the world's leading equipment, hardware, software, training and integration companies in the business. We are closely connected with food safety and other audit activities and can begin an initial assessment of your capabilities and needs. Ryan Systems works with partners whose products have proven themselves to be positioned for future quality system needs.
Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON, San Diego, CA
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
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