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FSMA: Preventive Controls for Human Food

  • The Lab by Royal Coffee NY 650 Hadley Road South Plainfield, NJ, 07080 United States (map)


Donna Schaffner

Associate Director:  Food Safety, Quality Assurance & Training at Rutgers University


This 20-hour class given over 2½ days covers information needed for becoming an FDA-recognized “Preventive Controls Qualified Individual” (PCQI) and gives information on how to create your company-specific Food Safety Plan meeting the FDA requirements as required by the Food Safety Modernization Act (FSMA).

Information is given for how to conduct a Hazard Analysis, and how to differentiate between pre-requisite programs and risk-based Preventive Controls, which could include Critical Control Points or not, depending on your situation and circumstances.  Also covered will be tips for choosing Critical Limits, setting-up Monitoring programs and how to implement Corrective Actions when Deviations occur. Documentation for all aspects of the PCHF-required Food Safety Plan including verification and validation activities, monitoring, corrective actions and records review will be covered in this course. 

This class is for FDA-required Food Safety Plans & is not required for USDA-regulated meats, Juice or Seafood products.

About the Course

Hands-on exercise sessions provide immediate utilization of lecture materials as participants work through a model Hazard Analysis and Food Safety Plan. Group discussions in the course allow for exchange of “best practices” advice on successful implementation and maintenance of Food Safety programs during everyday production.  A written exam at the end of the course offers an evaluation of how well participants understand the material. 

Passing the test is required for earning a certificate. 

Participants receive a PCHF textbook, Participant Workbook and handouts of forms and examples for producing their company-specific Food Safety Plans. 

Participants attending all 20 hours of the workshop and passing a written exam on the last day of the class will receive via e-mail an individually-numbered  Certificate of Completion from the Association of Food and Drug Officials, to satisfy specific FDA requirements to become a “P.C. Qualified Individual”. 

Cost of $745 per person paid to the Rutgers Food Innovation Center includes the $50 per person certificate fee paid directly to the FSPCA through their on-line Learning Management System. You make one payment to the FIC, and the instructor manages your registration and certificate fee with the FSPCA and AFDO.  Course fee includes 2 books, printed forms & supporting materials.  AFDO Certificate will be available on-line after completion of the class and successful passing of the written exam. Also included are tea, coffee & snacks all three days, and lunch on days 1 & 2.

Payment by credit card, purchase order, or check payable to the Food Innovation Center must be received prior to start of class; space in the class will be held only after (non-refundable) payment is received. 

NOTE: Class-size is limited, with seats guaranteed only after payment is received, on a first-paid-first-reserved basis so please don’t delay. 

For online registration:  

Or contact:

Polly Pepper at 856-459-1900 x4521,

or Regina Plaire x4515,

Course Schedule

Day 1: 8 hrs (8:30AM-12:00, lunch, 12:30-5:00PM)

Introduction & Objectives, sign-in sheets

 Preventive Controls Overview  Chapter 1

Food Safety Plan Overview  Chapter 2

GMPs and Prerequisite Programs   Chapter 3

Biological Food Safety Hazards   Chapter 4

Chemical, Physical & Economically Motivated

Food Safety Hazards   Chapter 5

Preliminary Steps in Developing a Food Safety Plan  Chapter 6

Resources for Preparing a Food Safety Plan  Chapter 7

Day 2: 8 hrs (8:30AM-12:00, lunch, 12:30-5:00PM)

Hazard Analysis & Preventive Controls Determination  Chapter 8

Process Preventive Controls  Chapter 9

Food Allergen Preventive Controls  Chapter 10

Sanitation Preventive Controls  Chapter 11

Supply Chain Preventive Controls  Chapter 12

Day 3: 4 hrs  (8:30AM-12:30)

Verification and Validation Procedures  Chapter 13

Record-keeping Procedures  Chapter 14

Recall Plan  Chapter 15

Regulation Overview – cGMP, Hazard Analysis and Risk-Based Preventive Controls for Human Food  Chapter 16

Workshop Overview/Summary

Written Exam

(AFDO Certificates available on-line immediately)


Please note, this course will take place at:

The Lab by Royal Coffee NY

650 Hadley Rd, South Plainfield, NJ, 07033

Please contact with any questions


Earlier Event: March 23
Tea Quality Control
Later Event: April 6
Introduction to Roasting, SOLD OUT