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
• Hazards requiring supply chain controls
• Hazards introduced for economic gain
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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.