Food Safety Modernisation Act (FSMA) FSPCA Preventive Controls for Human Food (PCQI Qualification Course)

Under US Code of Federal Regulation CFR 117 each food manufacturer in the US must have a Preventive Controls Qualified Individual (PCQI).  This individual must have successfully completed training in the development and application of risk base preventive controls using a standardized curriculum recognized by the FDA.  The Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food regulation) is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. The regulation requires that certain activities must be completed by a “preventive controls qualified individual.” This course, developed by FSPCA, is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual.” Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” include to oversee or perform
  1. Preparation of the Food Safety Plan
  2. Validation of the preventive controls
  3. Records review
  4. Reanalysis of the Food Safety Plan, and other activities as appropriate to the food
The FSMA concept is to move away from a reactive approach towards a preventive system. With FSMA there are seven rules which are specific to different types of foods, elements of the supply chain and stakeholders.  With this level of complexity and change, the challenge for Irish indigenous and Irish based multinational food companies is to understand how these rules will affect their current Food Safety Management Systems. The Food Safety Modernisation Act (FSMA) is the most significant change to US Food Safety legislation in over 70 years.  The act was signed into law by President Obama in 2011.  FSMA is in response to numerous food poisoning incidents that have occurred in the US over the past ten years.  Figures released by the USDA estimate that each year over 48 million Americans become ill from food poisoning, resulting in 50,000 hospitalisations and over 3,000 deaths.  

Figure 1Figure 2

Figure 1 & Figure 2 from the Food Safety Preventive Control Alliance (FSPCA) above show the similarity and difference between HACCP and FSMA.  Both employ a similar logic however, FSMA moves away from the traditional HACCP approach of just being focused on the manufacturing process to address the entire supply chain.  It also stresses the point that most food poisoning incidents are not due to CCP failures hence the focus on Preventive Control Procedures, PCPs. Figure 3 below of a “preventive food safety system” identifies how FSMA requires four of the traditional GFSI pre-requisites of supply chain programme, allergen control, sanitation control and recalls plan to be included in the Food Safety Plan.  This is in direct response to what was seen as major flaws in recent US food poisoning investigations most noticeably in the salmonella typhimurium contamination of peanut products.

Figure 3


Delivery Mode

  • Public

    23 - 25 Feb 2021
  • Public Virtual

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  • Customised

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What's covered?

Day One

  • Chapter 1 Introduction to Course and Preventive Controls
  • Chapter 2 Food Safety Plan Overview
  • Chapter 3 Good Manufacturing Practices and Other Prerequisite Programs
  • Chapter 4 Biological Food Safety Hazards
  • Chapter 5 Chemical, Physical and Economically Motivated Food Safety Hazards
  • Chapter 6 Preliminary Steps in Developing a Food Safety Plan
  • Chapter 7 Resources for Preparing Food Safety Plans

Day Two

  • Review and Questions
  • Chapter 8 Hazard Analysis and Preventive Controls Determination
  • Chapter 9 Process Preventive Controls
  • Chapter 10 Food Allergen Preventive Controls
  • Chapter 11 Sanitation Preventive Controls
  • Chapter 12 Supply‐chain Preventive Controls

Day Three

  • Review and Questions
  • Chapter 13 Verification and Validation Procedures
  • Chapter 14 Record‐keeping Procedures
  • Chapter 15 Recall Plan
  • Chapter 15 Recall Plan
  • Chapter 16 Regulation Overview – cGMP, Hazard Analysis, and Risk‐Based Preventive Controls for Human Food

Who should participate?

  • Quality / Technical Managers
  • Food Safety Team Leaders
  • Food Safety Team Members
  • Purchasing / Supply Chain Personnel
  • Internal Audit Personnel
  • Compliance Personnel
  • 2nd Party Supplier Auditors

What will I learn?

Participants achieve the following learning outcomes from the programme;

  • Understand why there is an enhanced focus on sanitation, allergen management, supplier controls and product recall
  • Understand Hazard Analysis & Risk Based Preventive Control (HARPC)
  • Understand the role of a PCQI
  • Understand the structured of the regulation (CFR Part 117) and the sub parts
  • Understand the structure and contents of the Food Safety Plan
  • Know the cGMP and Pre-Requisites
  • Understand how to make an Irish / European HACCP system FSMA compliant

Who are the tutors?

Denis Kiely

Denis has 25 years of experience working in various sectors of the Food Industry specialising in Food Safety / HACCP, Process Control, Legal Compliance and Auditing.  His main skill is removing the jargon and mystique attached to what is now considered the most important element of business continuity in the food industry, food safety.  Denis has worked with competent authorities both Irish and European, multinational food and beverage manufacturers plus Irish SME food business’.  He also has extensive experience working with Irish, UK and European retailers.

The manufacturer and retail of safe food requires investment in the three Ps; Premises, Plant & People.  The last of these – People – arguably the most important but perhaps least reliable if not trained well.  This is the key message that Denis focuses on in all training programmes he delivers regardless of the audience.  Food Safety must be taken out of the laboratory or technical department and brought down to factory floor level.  This can only be done with strong leadership and excellent communication skills where the concept of team and collective responsibility is fostered and rewarded.

Denis has a BSc Food Science & Technology, is a Registered Food Safety Auditor with IRCA (International Register of Certificated Auditors), an elected Fellow of the Royal Society for Public Health, an Associate Member of Chartered Quality Assurance and holds an NUI Certificate in Training & Continuing Education. Denis has worked at management level in a number of food industries and is one of Ireland’s leading experts on Food Safety and is constantly in demand by major food manufacturers and food retailers for his expertise in this area. He is a gifted trainer, expert at delivering complex information in plain English in language that is clearly understood, ensuring delegates leave his training programmes empowered with new knowledge and confident to implement.

Denis is a Licensed trainer with CIEH (Chartered Institute of Environmental Health UK).  Denis Kiely is a Qualified PCQI and a Qualified Lead Instructor in Preventive Controls for Human Food.

How do we train and support you?

In-House Courses
For In-House courses, the tutor will contact you in advance to discuss the course programme in more detail.

Course Manual
Delegates will receive a comprehensive course manual (FSPCA Participant Manual) as well as exercise Workbook and teaching examples.

Programme accreditation

The certificate is issued by the International Food Protection Training Institute (IFPTI). The IFPTI serves food protection professionals in the United States and the rest of the world, improves public health through competency-based learning solutions while cultivating strong leadership in the global food protection community.

The Food Safety Preventive Controls Alliance (FSPCA) is a broad-based public private alliance consisting of key industry, academic and government stakeholders whose mission is to support safe food production.  The FSPCA has developed a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that will be part of the Food Safety Modernization Act (FSMA).

Delegates who attend will become qualified PCQIs and will be able to download their PCQI certificate on course completion. Mandatory attendance for the entire programme is required to achieve certification.

Denis Kiely

Duration: 2.5 daysPublic Price: €1,020
+ €75 (certification fees)

Food Safety Modernisation Act (FSMA) FSPCA Preventive Controls for Human Food (PCQI Qualification Course)

Duration: 2.5 daysVirtual Training Price: €995
+ €75 (certification fees)
  • 23 - 25 Feb 2021
    Virtual Training Book Date

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