The decision of when and which validation study approach to adopt

The PCQI course participants often showed a particular interest in the topic of validation, when and how to validate, what is acceptable and what is not, with regards to compliance with the FDA requirements. The Preventive Controls for Human Food requirements stipulate in 21 CFR 117.160: (a) You must validate that the preventive controls identified and

The All-Too-Human Causes of Food Safety System Shortfalls

Moving from knowledge-based to behavior-based training might be key to culture change An article published in the Food Safety Magazine, August 12, 2021 Given the continued growth of trade agreements and exchanges between countries and the evolution of production methods to meet international market needs, our food supply has developed significantly over the last several

COVID-19 Preparedness in the Food Industry

On 11 March 2020, the outbreak of coronavirus disease (COVID-19) has been declared a global pandemic by the World Health Organization as the virus has spread to many countries. It’s the first time the WHO has called an outbreak a pandemic since the H1N1 “swine flu” in 2009. What is confirmed is that the virus

Temporary COVID-19 Policy for Receiving Facilities in Meeting FSMA Supplier Verification Onsite Audit Requirements

As the global pandemic of COVID-19 continues to bring about turmoil and health threats, the U.S. Food and Drug Administration issued guidance to communicate the temporarily drop of the supplier verification onsite audit requirements for receiving facilities and importers under the  FDA Food Safety Modernization Act (FSMA) provided other supplier verification methods are used instead. The Preventive Controls for Human Food (PC Human

COVID-19 Preparedness in the Food Industry

On 11 March 2020, the outbreak of coronavirus disease (COVID-19) has been declared a global pandemic by the World Health Organization as the virus has spread to many countries. It’s the first time the WHO has called an outbreak a pandemic since the H1N1 “swine flu” in 2009. What is confirmed is that the virus