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Course designed to help companies fulfill PCQI requirement under FSMA will be taught by former FDA investigator.
June 7, 2017
By: Sean Moloughney
Editor
The United Natural Products Alliance (UNPA) is launching a new training course, “Preventive Controls Workshop for Dietary Supplements: PCQI Training for Dietary Supplement Companies,” to be taught by former FDA Investigator Larisa Pavlick, UNPA’s vice president, Global Regulatory and Compliance. This 2.5-day PCQI training course will be held July 17-19, in Salt Lake City, UT. Successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual” (PCQI) as required by the Food and Drug Administration (FDA) as part of the Food Safety Modernization Act (FSMA). A PCQI is a professional that can oversee or perform the preparation of a Food Safety Plan, validation of the preventive controls, records review, reanalysis of the Food Safety Plan, and other activities as appropriate to the product. This person should have successfully completed training in the development and application of risk-based preventive controls. UNPA’s PCQI training is limited to 30 attendees. UNPA members receive a $200 registration discount. This UNPA training course provides exercises specific to dietary supplements. The Food Safety Preventive Controls Alliance (FSPCA) developed the remainder of the course, which is the “standardized curriculum” recognized by FDA. Ms. Pavlick, who is a PCQI, has completed PCQI Lead Instructor training through FSPCA. “In our continuing efforts to raise the bar around industry quality initiatives and to encourage compliance with all federal regulations, UNPA is pleased to offer this important new training to help supplement companies meet the stringent requirements of FSMA,” said Loren Israelsen, UNPA president. “And as per FSPCA requirements, only 30 attendees will be able to take advantage of this detailed course offering.” “This course is an efficient and comprehensive way for dietary supplement company personnel to achieve PCQI certification under FSMA,” said Ms. Pavlick. “With the addition of workshop examples specific to the supplement industry, it’s highly targeted and will be of great value to all companies that manufacture dietary supplements or dietary ingredients.” At the end of this training program, participants will be able to:
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