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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).

Are You Amazon Ready?

As we learn more about Amazon and its relatively new and evolving dietary supplements quality policy, the responsibilities of companies selling these products on Amazon’s platform are becoming more apparent.

PCQI: What Type of Investment Do I Need to Make?

The role of the Preventive Controls Qualified Individual (PCQI) takes center-stage when determining corporate compliance within the U.S. Food and Drug Administration’s (FDA) Hazard Analysis and Risk-based Preventive Control (HARPC) rule.

FSMA: Designing and Implementing the Food Safety Plan

Are you being asked to design and implement a Food Safety Plan for your organization? Is it giving you anxiety? Are you hoping to find a definitive guide to meet the Food Safety Modernization Act's (FSMA) requirements, exceed your company's...

Are You a “Qualified Individual” According to FSMA?

If you are a Food Safety and Quality Assurance (FSQA) professional, how do you know if you are "qualified" under the Food Safety Modernization Act (FSMA) to be involved in the development and oversight a food safety plan?

Preventive Controls Qualified Individual

The FDA’s Preventive Controls for Human Food regulation applies to facilities required to register with FDA under section 415 of the Food, Drug, & Cosmetic Act. These facilities must comply if they manufacture, process, pack, or hold human food....