Do you export food to the USA ?

All food producers (domestic producers and international exporting organizations) (i.e., food manufacturers, processors, packers, and distributors), except USDA regulated meat, poultry, and processed egg producers, are required to comply with general FSMA requirements unless otherwise exempted.

On January 4, 2011, the Food Safety Modernization Act (FSMA), the first major reform of the US Food and Drug Administration (FDA) in over 70 years, was signed into law. This sweeping and historic act is intended to shift FDA focus to better protect public health by preventing food safety issues rather than reacting to outbreaks.  The FDA Food Safety Modernization Act (FSMA) aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

The FSMA Preventive Controls rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule” is one of the seven rules that is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. The regulation requires domestic and international food facilities (i.e., food manufacturers, processors, packers and distributors) that are registered with the FDA to develop and implement a Food Safety Plan that complies with the requirements and that certain activities must be completed by a “Preventive Controls Qualified Individual” (PCQI)

The FSMA Preventive Controls rule requires that certain activities must be completed by a preventive controls qualified individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls.

Become a PCQI (Preventive Controls Qualified Individual) Human Food

DFK for Safe Food Environment offers you the accredited FSPCA PCQI training courses and services to assist you in compliying with the FSMA PCHF rule

This course is developed by the Food Safety Preventive Controls Alliance. It is the standardized curriculum recognized by the FDA designed to help participants meet the PCQI requirements and assist the food facilities to achieve compliance with the FSMA requirements.

Successful completion of this course will :

  • Offer you a complete understanding of the requirements of the Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation
  • An FDA-recognized FSPCA Preventive Controls Qualified Individual certificate issued by AFDO, IFSH and IFPTI
  • Course description

    The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based 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 (PCQI).

    This 2.5-days PCQI course is developed by the Food Safety Preventive Controls Alliance (FSPCA) and is the only “standardized curriculum” recognized by the Food and Drug Administration. It is designed to help the participants to meet the FDA’s PCQI training requirements, understand the requirements of the Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food, and develop and implement the Food Safety Plan according to the Preventive Controls Human Food regulation.

  • Prerequisites

    Prior knowledge of GMP’s and HACCP, and/or experience with Food Safety Management Systems, is highly recommended.

  • Course contents

    Module One
    The Food Safety Modernization Act: Advancing Prevention Focused Food Safety Systems

    Module Two
    Personnel: Roles and Responsibilities for Food Safety

    Module Three
    Identifying & Evaluating Hazards in the Production Environment

    Module Four
    Hazard Analysis and The Process Flow Diagram

    Module Five
    The Written Food Safety Plan

    Module Six
    Sanitation, Allergen and Environmental Controls

    Module Seven
    Supply Chain Controls

    Module Eight
    The Recall Plan and Recordkeeping with Related Supplier/Audit Actions

    Module Nine
    Putting it all Together – Building the Food Safety Plan

    Module Ten
    Food Safety Plan Outline: Final Project

  • Assessment

    Learners will be assessed on their ability to meet the course objectives. They must demonstrate :

    • Completion of assigned tasks and understanding of the requirements
    • Active participation in class discussions
    • Complete attendance

    Upon successful completion of the course, learners will receive their official FSPCA PCQI certificate issued by the Association of Food and Drug Officials (AFDO).

  • Duration

    The duration of the training course is 20 hours (2.5 days).

OUR CLIENTS

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    Lallemand GmbH

    FSMA GAP Analysis- Vienna, Austria

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    LeRo Food GmbH & Co. KG

    PCQI training for LeRo Food GmbH & Co. KG – Leipzig, Germany

     

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    Nestle Deutschland AG - Osthofen, Germany

    PCQI In-house Training for Nestle Deutschland AG – Osthofen, Germany

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    DMK Eis - Everswinkel, Germany

    PCQI In-house Training for DMK Eis – Everswinkel, Germany

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    Freiberger Lebensmittel- Berlin, Germany

    FSPCA PCQI in-house Training for Freiberger Lebensmittel- Berlin, Germany

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    Public PCQI For Human Food Training

    A public FSPCA PCQI for Human Food workshop was held in Hamburg on 6-8 November 2019. Nine participants, food professionals from various food processing companies –  AB Enzymes GmbH,Josef Manner & Comp. AG, BASF SE, Dr.A ugust Oetker Nahrungsmittel KG, Josef Manner & Comp. AG, Miller conSup  Gesellschaft fuer Import und Export GmbH, Agrarfrost GmbH & Co. KG, IOI Oleo GmbH, and Jacobs Douwe Egberts DE GmbH, joined us and successfully completed the training. Congratulations to our new PCQIs !

Book your place now in our PCQI workshops and learn how to achieve FSMA compliance

In-house PCQI training course can also be arranged at a time and location that suit your organization's needs!

The FSMA Preventive Controls Qualified Individual Training courses for the year 2019 are scheduled and more dates and venues are yet to be arranged. Book your course here or navigate the calendar for more convenient dates.

We invite you to sign up for our newsletter to be upfront with our news and PCQI course schedule.

9 Septemeber 2019: For the second year in a row, the chamber of Commerce in Hanover organizes FSMA-related workshops  for the agricultural and food industry and the medical and health industry. The event ” Sales Workshop USA: FDA Regulations” took place in Hannover on the 9th of September 2019.

DFK joined as a speaker and presented “Exporting to the United States? What you need to know on FSMA rule for Food Facilities“.

Both workshops hosted a number of experts giving talks and presentations on several important issues related to exporters to the US: sales, marketing channels, compliance issues and regulatory requirements. Many interesting questions on FSMA during the B2B meetings reflected the importance of such interactive discussions and close communication.

17 September 2018: DFK was invited as a speaker to join the leading experts in the food industry and trade from the US, Canada and Germany in the Food Forum USA and Canada organized by the German Chamber of Commerce and Industry in Hannover.

The forum featured presentations, experts talks, and conversations on several important trade and regulatory issues that German companies need to know, these included: industry patterns and current market trends, customer habits, import regulations or distribution channels.

DFK presented an overview on the FSMA key requirements, registrations of food facilities, the role of different US agencies and the US agents, and what the industry should know and do to prepare for the FDA FSMA inspections.