PCQI Training

HCG helps companies comply with commercial and regulatory requirements. This includes providing FDA Food Safety Preventive Controls Training. Our lead instructors explain this part of FSMA and offer practical advice on what to do next. Read more…

Labeling

Labeling errors are a common cause for product recalls due to misbranding. HCG will work with your business to help ensure your labels are accurate and in compliance with regulations. We offer assistance on:

  • Individual label development or reviews for FSIS or FDA regulated products
  • Individual label development or reviews for products to be shipped to Mexico, Canada, or other countries
  • Comprehensive labeling system reviews
  • Implementation or review of label management systems to ensure ongoing control within your process
  • Development of Child Nutrition programs including Child Nutrition labeling for the National School Lunch Program

A label or labeling system review from HCG can help minimize the vulnerability of your labels and labeling to regulatory action to help ensure:

  • Greater confidence in label accuracy
  • Lower risk for recalls, regulatory reviews, or potential lawsuits for “misleading” the consumer
  • Lower cost associated with a streamlined, efficient label review and control plan

A label and labeling system review is also a cost effective way to increase confidence and strengthen your labeling control system. Our reviews include:

  • Examining samples of the types of labels and labeling you use for your products and reviewing the content against the regulatory requirements for the type of product you are labeling
  • Evaluating all inputs to generating your labels and labeling
  • Assessing your internal system of handling labels and labeling
  • Verifying or assisting with improving training for those involved in labels and labeling within your company
  • Providing recommendations from the findings in the audit

Contact us for details.

FDA Regulatory Compliance

Food and Drug Administration (FDA) Services

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur.  The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities. The Current Good Manufacture Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods regulation is part of FDA’s implementation of FSMA.

First, the Preventive Controls rule modernizes FDA’s long-standing current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food.

Second, the PC rule creates new requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. As part of the rule it is also required that each facility have one or more “Preventive Controls Qualified Individuals PCQIs” responsible for the development, implementation and maintenance of the firm’s food safety plan. To address this requirement the Food Safety Preventive Controls Alliance has developed a standardized curriculum recognized by the FDA as one way to meet the requirements for a PCQI.

HCG Preventive Controls Training

The HCG has qualified Lead Instructors available to provide public or in-house Preventive Controls training to address the requirement of the PC regulations.  Students attending the PC training will receive a certificate as a Preventive Controls Qualified Individual.

HCG HACCP/PC Training

To accommodate the needs of the food industry where it might be necessary to have a HACCP plan as part of a Global Food Safety Initiative program and a Preventive Controls food safety plan to meet FDA requirements, the HCG has developed a combined, and recognized, training program to meet both needs.  This HACCP/PC training program has been recognized by both the International HACCP Alliance (IHA) as well as the Food Safety Preventive Controls Alliance.  As a result, students receive both a HACCP Certificate with an IHA seal as well as a Certificate as a Preventive Controls Qualified Individual.

Assistance in Development Food Safety Plans and Systems

HCG Professionals can conduct GAP analyses of food plants’ food safety plans and systems as well as assist food plants to develop, implement and maintain food safety plans in compliance with FDA regulations. HCG professionals can also assist plant management prepare for FDA investigations by reviewing its food safety plan and system, GMP/Prerequisite programs, supporting documentation, process validation documentation, plant pathogen control programs,  plant sanitation procedures and plant records.

HCG Recall and Crisis Management Assistance

There can come a time when even the best run plant can find itself in a recall or crisis situation.  An ingredient supplier might change formulations or an employee may mistakenly release product under testing.   If not handled correctly, these situations can bring all plant operations under a regulatory microscope and cause uncontrollable operational or in the worst cases, legal costs.

Having a HCG professional at your side can help contain a crisis and put a plant back in operation.  HCG can help investigate the cause of the crisis, suggest actions to prevent the risk of further occurrences, act as a liaison between plant management and regulatory personnel, and assist with responding to government enforcement actions in order to return plant operations to a state of compliance.

Other Assistance

The HCG can also offer assistance to plants addressing FDA’s FD 483 findings  Letters of Warning, positive finding of pathogens in ready-to-eat products, etc.