Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans

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The U.S. Food and Drug Administration (FDA) requires most registered food facilities to implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans.

A HARPC plan must be written and overseen by a Preventive Controls Qualified Individual (PCQI).

If you process certain foods for U.S. consumption without a HARPC plan, your facility may be non-compliant with FDA regulations.

HARPC introduces components not addressed by HACCP. Under HARPC, most facilities are required to establish:

•         A Recall Plan

•         A Supply Chain Program

 HARPC plan must also consider:

•         Radiological hazards

•         Allergens

•         Hazards requiring supply chain controls

•         Hazards introduced for economic gain

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Speaker: Kelly Thomas, Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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