Preventive Controls Qualified Individual: The What, Who, Why and How

The Food and Drug Administration’s (FDA) Hazard Analysis and Risk-based Preventive Control (HARPC) rule relies heavily upon tasks performed by a “Preventive Controls Qualified Individual” (PCQI).

HACCP and HARPC: Key Differences and Definitions

The U.S. Centers for Disease Control and Prevention (CDC) estimates that at least 48 million Americans contract a foodborne illness every year, resulting in about 128,000 hospitalizations and 3,000 deaths.

FSMA: A Few Frequently Asked Questions

FDA Attorney Marc Sanchez is a frequent national speaker on FDA compliance issues affecting the food, dietary supplement, and medical device industries, and is also widely considered a leading voice in understanding the Food Safety Modernization...

Decoding HARPC

Under the Hazard Analysis and Risk-Based Preventive Controls (HARPC) regulations, mandates for food facilities in the United States require compliance with regulations, standards, and guidance above and beyond those of HACCP (Hazard Analysis and...