About Course
COURSE DESCRIPTION
The Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation is intended to ensure the safe manufacturing, processing, packing, and holding of food products for human consumption in the United States.
This regulation requires that certain activities be performed by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls, at least equivalent to that received under a standardized curriculum recognized by the FDA, or who is otherwise qualified through job experience.
This course, developed by the Food Safety Preventive Controls Alliance (FSPCA), is the standardized curriculum recognized by the FDA. Successful completion of this course is one way to meet the requirements for a PCQI.
TARGET AUDIENCE
This course is intended for companies that manufacture, process, pack, or hold human food and must comply with the Preventive Controls for Human Food regulation under the Food Safety Modernization Act (FSMA). It is especially relevant for small and medium-sized businesses. Individuals in academia or government may also find this course useful.
COURSE OVERVIEW
This standardized, industry-oriented training provides participants with the knowledge necessary to develop a Food Safety Plan in compliance with the Preventive Controls for Human Food regulation.
The course content focuses on food safety activities and documentation required to create and implement a preventive controls-based Food Safety Plan.
Training materials include the FSPCA participant manual, presentation slides, explanations of key terms and concepts, practical exercises using Food Safety Plan examples, an exercise workbook, and reference materials. These materials are designed to meet the training requirements outlined in 21 CFR 117.180(c)(1) for individuals responsible for Food Safety Plan activities.
PURPOSE
To explore the regulatory requirements of the U.S. Food and Drug Administration’s (FDA) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
COURSE GOAL
To develop a Food Safety Plan and implement preventive controls to mitigate and control identified food safety hazards.
Course Content
FSPCA PCQI 2.0 SELF PACED CHAPTER 0
PREFACE: OVERVIEW OF THE FSPCA PREVENTIVE CONTROLS FOR HUMAN PARTICIPANT COURSE
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Chapter 0 Intro Video
01:13 -
CHAPTER 0 NOTES
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FULL CHAPTER 0 FROM MANUAL
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Chapter 0 lecture PCQI 2.0
11:17 -
Additional Reading, Resources, and References
FSPCA PCQI 2.0 SELF PACED CHAPTER 1
FOOD SAFETY PLAN OVERVIEW FOR PREVENTIVE CONTROLS FOR HUMAN FOOD
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Chapter 1 Intro video
01:34 -
CHAPTER 1 NOTES
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FULL CHAPTER 1 FROM MANUAL
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Chapter 1 lecture PCQI 2.0
35:11 -
CHAPTER 1 QUIZ
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APPENDIX 8 DEFINITIONS
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APPENDIX 1
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CODEX ALIMENTARIUS PROCEDURAL MANUAL
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GENERAL PRINCIPLES OF FOOD HYGIENE
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NACMCF HACCP PRINCIPLES AND APPLICATION 1998 JOURNAL OF FOOD PROTECTION
FSPCA PCQI 2.0 SELF PACED CHAPTER 2
CURRENT GOOD MANUFACTURING PRACTICE AND PREREQUISITE PROGRAMS FOR HUMAN FOOD
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Chapter 2 Intro Video
01:34 -
CHAPTER 2 NOTES
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FULL CHAPTER 2 FROM MANUAL
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Chapter 2 Lecture PCQI 2.0
55:52 -
CHAPTER 2 QUIZ
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FOOD DEFECT LEVELS HANDBOOK
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21 CFR 117 B
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SNAPSHOTS IN SANITARY EQUIPMENT
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FoodNet Fast: Pathogen Surveillance Tool
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SANITATION FOR SEAFOOD
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FOOD PLANT SANITATION DESIGN
FSPCA PCQI 2.0 SELF PACED CHAPTER 3
BIOLOGICAL FOOD SAFETY HAZARDS FOR HUMAN FOOD
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Chapter 3 intro video
01:44 -
CHAPTER 3 NOTES
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FULL CHAPTER 3 FROM MANUAL
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Chapter 3 Lecture PCQI 2.0
01:14:06 -
CHAPTER 3 QUIZ
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FDA. 2004. Guidance for Industry: Juice HACCP Hazards and Controls Guidance 1st Edition; Final Guidance.
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Barbosa‐Canovas, G. et al. 2007. Water Activity in Foods: Fundamentals and Applications, Blackwell Publishing and the Institute of Food Technologists. INTRODUCTION
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Fish and Fishery Products Hazards and Controls Guidance JUNE 2022
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Reportable Food Registry
14:23 -
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry Draft Guidance JANUARY 2024
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Dairy Grade A Voluntary HACCP.
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Bad Bug Book Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins
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FDA. 2014. Foodborne Illness‐Causing Organisms in the U.S. What You Need to Know
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FDA MODEL FOOD CODE 2022
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Centers for Disease Control and Prevention AND Food Safety
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FOODBORNE PATHOGEN SUPPLEMENTARY INFORMATION
FSPCA PCQI 2.O SELF PACED CHAPTER 4
CHEMICAL, PHYSICAL, AND ECONOMICALLY MOTIVATED FOOD SAFETY HAZARDS FOR HUMAN FOOD
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Chapter 4 intro video
01:36 -
CHAPTER 4 NOTES
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FULL CHAPTER 4 FROM MANUAL
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Chapter 4 Lecture PCQI 2.0
01:04:25 -
CHAPTER 4 QUIZ
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American Academy of Pediatrics. 2010. Policy Statement – Prevention of Choking Among Children. Pediatrics 125(3):601‐607.
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Congressional Research Service. 2014. “Food fraud and “economically motivated adulteration” of food and food ingredients, January 10, 2014
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Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed
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FDA. 2005. Foods ‐ Adulteration Involving Hard or Sharp Foreign Objects. Compliance Policy Guidelines 555.425.
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Everstine, K., J. Spink, S. Kennedy. 2013. Economically motivated adulteration (EMA) of food: common characteristics of EMA Incidents, J Food Protection 76:723‐735.
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Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry
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Recalls Associated with Food Allergens and Gluten in FDA-Regulated Foods from Fiscal Years 2013 to 2019
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Analysis of U.S. Food and Drug Administration Food Allergen Recalls after Implementation of the Food Allergen Labeling and Consumer Protection Act
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Agents Classified by the IARC Monographs, Volumes 1–135
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FDA. 2006b. Supporting document for recommended maximum level for lead in candy likely to be consumed frequently by small children, November, 2006.
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Milani, J. and G. Maleki. 2014. Effects of processing on mycotoxin stability in cereals. J. Sci. Food Agr. 94:2372‐2375.
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U.K. Food Standards Agency. 2005. Sudan I timeline, February 24, 2005.
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Stratton J.E., RW Hutkins SL. Taylor 1991. Biogenic amines in cheese and other fermented foods: a review. J. Food Protection 54(6):460‐470.
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Anon. 1995. Adulteration of paprika in Hungary. LEAD Action News 3(3).
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Guidelines for drinking-water quality
FSPCA PCQI 2.O SELF PACED CHAPTER 5
PRELIMINARY STEPS IN DEVELOPING A FOOD SAFETY PLAN FOR HUMAN FOOD
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Chapter 5 intro video
01:21 -
CHAPTER 5 NOTES
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FULL CHAPTER 5 FROM MANUAL
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Chapter 5 Lecture PCQI 2.0
25:46 -
CHAPTER 5 QUIZ
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National Advisory Committee on Microbiological Criteria for Foods. 1998. Hazard Analysis and Critical Control Point Principles and Application Guidelines. Journal of Food Protection 61(9):1246‐1259.
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FAO/WHO. 2003. Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for Its Application Annex to CAC/RCP 1‐1969, Rev. 4 ‐ 2003
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FDA. 2014. Dairy Grade A Voluntary HACCP
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FSPCA FOOD SAFETY WORKSHEETS
FSPCA PCQI 2.0 SELF PACED CHAPTER 6
HAZARD ANALYSIS FOR HUMAN FOOD
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CHAPTER 6 NOTES
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FULL CHAPTER 6 FROM MANUAL
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Chapter 6 Lecture
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Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition
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MEAT AND POULTRY HAZARDS AND CONTROLS GUIDE
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Food Safety Plan Worksheets
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Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry Draft Guidance
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Preventive Controls for Human Food First Edition – 2016
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FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDE JUNE 2022
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CHAPTER 6 QUIZ
FSPCA PCQI 2.0 SELF PACED CHAPTER 7
PREVENTIVE CONTROLS DETERMINATION FOR HUMAN FOOD
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CHAPTER 7 NOTES
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FULL CHAPTER 7 FROM MANUAL
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Chapter 7 Lecture PCQI 2.0
30:19 -
CHAPTER 7 QUIZ
FSPCA PCQI 2.0 SELF PACED CHAPTER 8
PROCESS PREVENTIVE CONTROLS FOR HUMAN FOOD-PARAMETERS AND VALUES, INCLUDING CRITICAL LIMITS
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CHAPTER 8 NOTES
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FULL CHAPTER 8 FROM MANUAL
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Chapter 8 Lecture PCQI 2.0
22:19 -
USDA Hazard Analysis Worksheet
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Hazard Analysis Worksheet
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Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry Draft Guidance
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§ 117.130 Hazard analysis
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National Advisory Committee on Microbiological Criteria for Foods. 1998. Hazard Analysis and Critical Control Point Principles and Application Guidelines. Journal of Food Protection 61(9):1246‐1259.
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EG FOOD HAZARD ANALYSIS
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Chapter 8 Assignment Broccoli, Carrot and Pecan Salad
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Chapter 8 Assignment Peanut Butter
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Chapter 8 Assignment Cold Pressed Almond Cranberry Energy Bar
FSPCA PCQI 2.0 SELF PACED CHAPTER 9
PROCESS PREVENTIVE CONTROLS FOR HUMAN FOOD-MONITORING AND CORRECTIVE ACTION
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CHAPTER 9 NOTES
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FULL CHAPTER CHAPTER 9 FROM THE MANUAL
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Chapter 9 Lecture PCQI 2.0
44:30 -
Canadian Food Inspection Agency. 2010. Guide to Food Safety Codex Alimentarius HACCP Documents
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Understanding FSMA: HACCP, HARPC and the Preventive Controls for Human Food Rule
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National Advisory Committee on Microbiological Criteria for Foods. 1998. Hazard Analysis and Critical Control Point Principles and Application Guidelines. Journal of Food Protection 61(9):1246‐1259
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FISH AND FISHERY PRODUCTS HAZARDS AND CONTROLS GUIDE
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EG FOOD PROCESS PREVENTIVE CONTROL
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OLD SCHOOL HACCP PLAN FORM
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NEW SCHOOL HACCP PLAN FORM
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PROCESS CONTROL FORMS
FSPCA PCQI 2.O SELF PACED CHAPTER 10
PROCESS PREVENTIVE CONTROLS FOR HUMAN FOOD-VERIFICATION AND RECORDKEEPING
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CHAPTER 10 NOTES
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FULL CHAPTER 10 FROM THE MANUAL
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Chapter 10 Lecture PCQI 2.0
00:00 -
EG FOOD VERIFICATION RECORDS
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Flores N.C. and E.A.E. Boyle. 2000 Thermometer Calibration Guide. Kansas State University.
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Brackett, R.E. et al. (2014) Validation and Verification: A Practical, Industry‐driven Framework Developed to Support the Requirements of the Food Safety Modernization Act (FSMA) of 2011. Food Protection Trends November/December 2014: 410‐425.
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IFT (Institute of Food Technologists) 2001. Evaluation and Definition of Potentially Hazardous Foods.
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Requisite Scientific Parameters for Establishing the Equivalence of Alternative Methods of Pasteurization
FSPCA PCQI 2.0 SELF PACED CHAPTER 11
FOOD ALLERGEN PREVENTIVE CONTROLS FOR HUMAN FOOD
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CHAPTER 11 NOTES
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FULL CHAPTER 11 FROM MANUAL
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CHAPTER 11 LECTURE PCQI 2.0
59:13 -
Chapter 11
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Food Allergy Research and Resource Program (FARRP) and Food Allergy and Anaphylaxis Network. Components of an Effective Allergen Control Plan – a Framework for Food Processors
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CLEANING AND SANITATION FOR THE CONTROL OF ALLERGENS
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ALLERGEN CROSS-CONTACT PREVENTION
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Gendel, S.M. and J. Zhu. 2014. 2013. Analysis of U.S. Food and Drug Administration food allergen recalls after implementation of the Food Allergen Labeling and Consumer Protection Act. J. Food Prot. 76(11) 1933‐1938.
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Jackson et al. 2008. Cleaning and other control and validation strategies to prevent allergen cross‐contact in food‐processing operations. J Food Prot. 71(2):445‐ 458.
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Pieretti, M.M., Chung, D., Pacenza, R., Slotkin, T., Sicherer, S.H. 2009. Audit of manufactured products: Use of allergen advisory labels and identification of labeling ambiguities. J Allergy Clin Immunol. 1242):337‐41
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Gendel, S.M., J. Zhu. N. Nolan, K. Gombas. 2014. Learning from FDA food allergen recalls and reportable foods. Food Safety Magazine. April‐May 2014:46‐52, 80
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Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry
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ALLERGEN PREVENTIVE CONTROL FORMS
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Institute of Agriculture and Natural Resources FOOD ALLERGY RESEARCH AND RESOURCE PROGRAM
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EG FOODS ALLERGEN PREVENTIVE CONTROLS
FSPCA PCQI 2.0 SELF PACED CHAPTER 12
SANITATION PREVENTIVE CONTROLS FOR HUMAN FOOD
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CHAPTER 12 NOTES
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FULL CHAPTER 12 FROM MANUAL
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Chapter 12 Lecture PCQI 2.0
01:00:57 -
Graham DJ. 2006. Snapshots in Sanitary Equipment: Developing an Eye for Hygiene. Food Safety Magazine.
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Graham, D.J. 2009. Equipment sanitary design considerations when purchasing. Food Safety Magazine.
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CONTROLLING PATHOGENS IN DAIRY PROCESSING ENVIRONMENTS
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APPENDIX 5 SANITATION BASICS
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21 CFR 117 SUBPART B
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Graham, D.J. 2004. Using Sanitary Design to Avoid HACCP Hazards and Allergen Contamination. Food Safety Magazine.
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EG FOOD SANITATION CONTROL PROCEDURES
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APPENDIX 6 HYGIENIC ZONING
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Pehanich, M. 2005. Designing food safety into your plant. Food Processing March 7, 2005
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3-A SANITARY DESIGN SECTION 1
00:00
FSPCA PCQI 2.0 SELF PACED CHAPTER 13
SUPPLY-CHAIN PREVENTIVE CONTROLS FOR HUMAN FOOD
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CHAPTER 13 NOTES
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FULL CHAPTER 13 FROM THE MANUAL
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Chapter 13 Lecture PCQI 2.0
01:28:08 -
CHAPTER 13 QUIZ
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INTERSTATE MILK SHIPPERS
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EG FOOD SUPPLY CHAIN PROGRAM
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Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry
FSPCA PCQI 2.0 SELF PACED CHAPTER 14
FOOD SAFETY PLAN IMPLEMENTATION AND MANAGEMENT FOR HUMAN FOOD
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CHAPTER 14 NOTES
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FULL CHAPTER 14 FROM THE MANUAL
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Chapter 14 Lecture PCQI 2.0
26:10 -
CHAPTER 14 QUIZ
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21 CFR 11
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Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
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Canadian Food Inspection Agency, 2010. Guide to Food Safety
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FSPCA FOOD SAFETY PLAN FORMS
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CODEX 60TH ANNIVERSARY
00:00
FSPCA PCQI 2.0 SELF PACED CHAPTER 15
RECALL PLAN FOR HUMAN FOOD
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CHAPTER 15 NOTES
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FULL CHAPTER 15 FROM MANUAL
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Chapter 15 Lecture PCQI 2.0
22:02 -
CHAPTER 15 QUIZ
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Directory of State and Local Officials
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Product Recalls, Including Removals and Corrections
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INVESTIGATIONS OPERATIONS MANUAL 2024 CHAPTER7 -RECALL ACTIVITIES
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Grocery Manufacturers Association 2008. Food Supply Chain Handbook.
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University of Florida, IFAS Extension. The Food Recall Manual
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Food Traceability
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FDA REPORTABLE FOOD REGISTRY
00:00
FSPCA PCQI 2.0 SELF PACED CHAPTER 16
REGULATION OVERVIEW-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISKED-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
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CHAPTER 16 NOTES
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FULL CHAPTER 16 FROM MANUAL
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Lecture Chapter 16 PCQI 2.0
31:50 -
CHAPTER 16 QUIZ
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APPENDIX 1 (21 CFR 117)
COURSE EVALUATION
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PARTICIPANT COURSE EVALUATION