The US Food Safety Modernization Act (FSMA)

Know more about FSMA
What does FSMA stand for?
  • FSMA stands for Food Safety Modernization Act.
  • The History of FSMA The FDA’s Food Safety Modernization Act (FSMA) is being called the most sweeping reform of U.S. food safety laws in more than 70 years. It was originally signed into law by President Obama on January 4, 2011, and in the years since, FDA has been working to develop the final rules that the act requires them to implement. The focus of the act is more effective prevention of food safety issues in the U.S. food supply.
  • FSMA is a comprehensive top-to-bottom overhaul of the United States food safety regulatory framework. FSMA will touch every segment of the produce business supply chain from farm-to-fork. The U.S. Food and Drug Administration (FDA) has proposed seven major regulations. The proposed regulations will affect how produce is grown, packed, processed, shipped and imported into the U.S. The Food Safety Modernization Act is changing the culture of the food safety system in the United States.
  • FSMA shifts the focus of the FDA to ensuring food safety through prevention of microbial contamination rather than just reacting to the problem after it has already occurred. With new changes in food safety regulations also come new compliance challenges for the food industry. Growers, producers, harvesters and processors need to fully comprehend the rules in order to overcome the challenges associated with FSMA. The Food Safety Modernization Act will require a multitude of standards to be met and procedures to be followed in order to comply with the law, below are a few noteworthy comments to help you in your journey to FSMA compliance.
  • Understanding FSMA One of the first challenges that companies will face when diving into FSMA is understanding the law and the rules which will implement it. These include preventive controls specific requirements for imported foods, food safety inspections, the sanitary transportation of foods and compliance timelines. Establishing where each rule fits, and which rules apply to food facilities can be overwhelming at first. Doing a gap analysis is a good idea for this first challenge, as it will let a company know their current standing and what future steps to take. Safe Food Alliance is working to make this transition easier for the food industry by pursuing FDA-approved training on the Produce Safety and Preventive Controls Rules. This will allow Safe Food Alliance to offer public and onsite training, as well as consultation services, for companies needing guidance-look for these classes in the coming year!
What triggers FSMA?
  • “As a result of the campaign launched in the aftermath of the PCA outbreak, President Barack Obama signed the Food Safety Modernization Act, which the FDA called the most sweeping reform in food safety laws in 70 years. “
  • The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It enables the FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.
  • A series of high profile food outbreaks generated increased consumers fear and interest, but 3 major events promoted the congress to sign FSMA into law:

    1. The 2006 E.coli multistates outbreak (26 US states) linked to frozen uncooked spinach sickened 200 people (100’s were hospitalized) and led to five deaths : There was an outbreak of food-borne illness caused by Escherichia coli (E. coli) bacteria found in uncooked spinach in 26 U.S. states.

    2. The 2007 melamine outbreak linked to contaminated pet food from China

    3. The 2008-9 salmonella outbreak where the Peanut Corporation of America (PCA) knowingly sold tainted peanut butter which killed nine people and sickened 714 others, some critically, across 46 states. The responsible person was sentenced to life behind bars for knowingly shipping out deadly food.
BECOME A PCQI FOR HUMAN FOOD

The official FSPCA PCQI training course is facilitated by Dr. Faour-Klingbeil, an approved lead instructor.

PCQI (Preventive Controls Qualified Individual) Course

Why it is important for food facilities to have PCQI? All food producers (domestic producers and international exporting organizations like 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) who has successfully completed training in the development and application of risk-based preventive controls.

The official FSPCA PCQI training course is facilitated by Dr. FaourKlingbeil, an approved lead instructor. Dr. Faour-Klingbeil is extensively leading public and in-house PCQI workshops across Germany and other EU countries. She has provided a number of advisory and consultancy services to internationally renowned food processors and assisted them in complying with the FSMA PCHF rule and preparing for the FDA audits.

FSMA COURSES

Dr. Faour-Klingbeil leverages her extensive background in research and her expertise as a lecturer in food safety laws and regulations to offer learning experience of the US Food Safety Modernization Act (FSMA) courses designed to empower your food safety team and ensure compliance with the FDA regulatory requirements.

Specializing in developing risk-based food safety systems and risk management, DFK for safe Food Environment offers a range of  options to suit your needs and facilitate compliance, all based on the standardized curriculum developed by the Food Safety Preventive Controls Alliance (FSPCA) and recognized by the FDA.

PCQI (Preventive Controls Qualified Individual) Course​

Why it is important for food facilities to have PCQI?

All food producers (domestic producers and international exporting organizations like 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) who has successfully completed training in the development and application of risk-based preventive controls.

The official FSPCA PCQI training course is facilitated by Dr. FaourKlingbeil, an approved lead instructor. Dr. Faour-Klingbeil is extensively leading public and in-house PCQI workshops across Germany and other EU countries. She has provided a number of advisory and consultancy services to internationally renowned food processors and assisted them in complying with the FSMA PCHF rule and preparing for the FDA audits.

BECOME A PCQI FOR HUMAN FOOD

The official FSPCA PCQI training course is facilitated by Dr. Faour-Klingbeil, an approved lead instructor.

Public PCQI Human Food Training:

Gain a thorough understanding of the FSMA Preventive Controls for Human Food rule through this intensive in-person program. This FSPCA-recognized curriculum covers Good Manufacturing Practices (GMPs), Hazard Analysis and Risk-Based Preventive Controls (HARPC), empowering participants to master the FSMA requirements.
This course is designed by the Food Safety Preventive Controls Alliance. It is the standardized curriculum recognized as adequate by the FDA to help participants meet the PCQI requirements and assist the food facilities to achieve compliance with the FSMA Preventive Control rule requirements.

Upon successful completion, you'll receive an FDA-recognized FSPCA Preventive Controls Qualified Individual certificate issued by AFDO, IFSH and IFPT , a valuable credential demonstrating your expertise to regulatory bodies.

In-House PCQI Human Food Training:

Boost your organization's food safety skills with an online or on-site PCQI workshop delivered just for your team. This program lets you focus on the special processes and challenges your facility faces, helping you understand the principles of the Food Safety Plan better and the FDA requirements.

Upon successful completion, you'll receive an FDA-recognized FSPCA Preventive Controls Qualified Individual certificate issued by AFDO, IFSH and IFPT , a valuable credential demonstrating your expertise to regulatory bodies.

Live-Online PCQI Human Food Training:

Embrace the flexibility of live, online learning with the virtual instructor-led online program. The course is offered via the Virtual Instructor Led video-conference approach and replicates the interactive nature of the traditional PCQI course, allowing participants to engage, collaborate, and complete assignments in real-time. Join me in this live-remote online course, save your time and budget. The training will follow the same curriculum and assignments, including breakout group work.

Ideal for busy professionals or those facing travel restrictions, this program delivers the same comprehensive curriculum and official FSPCA PCQI certificate upon successful completion.

Protect your brand, ensure consumer safety, and and achieve regulatory compliance with DFK's highly acclaimed expertise in FSMA standards.

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