If you are a facility subject to the CGMP & PC rule and no exemptions from Subparts C (Hazard Analysis and Risk-based Preventive Controls) and G (Supply-Chain Program) apply to you, then you are required to have a Preventive Controls Qualified Individual (PCQI) develop and implement your facility’s food safety plan (21 CFR 117.180(a)). A PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum (21 CFR 117.180(c)(1)).
FSPCA has developed a standardized curriculum recognized by FDA; and successfully completing this course is one way to meet the requirements for a PCQI.
These courses are taught by Lead Instructors trained by the FSPCA, who have been instructed in how to teach the FDA-recognized standardized curriculum.
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