UNPA announces in-house PCQI training for food and supplement companies after completion of in-house PCQI training for Indena

MILAN, Italy (July 17, 2017) — The United Natural Products Alliance (UNPA) has begun providing onsite Preventive Controls Qualified Individual (PCQI) training for food and dietary supplement companies after the successful completion of a PCQI training session for UNPA member Indena at its corporate headquarters in Milan, Italy.

In addition to the recent Salt Lake City PCQI training, UNPA’s Larisa Pavlick, VP, Global Regulatory & Compliance, who is a former Food and Drug Administration (FDA) investigator, leads a team of highly experienced PCQI Lead Instructors that are available to provide in-house training for food and supplement companies that are required to have a PCQI as part of the Food Safety Modernization Act (FSMA). Most companies producing organic and natural foods, dietary supplements and dietary ingredients face a September 2017 compliance date to have a PCQI on staff. 

In early July, UNPA completed a PCQI training for Indena, a leading ingredient supplier, in Milan, Italy, taught by Pavlick. Indena had 12 employees from four locations present for the training. All 12 team members successfully completed the 20-hour (2.5 day) standardized curriculum. In addition, five observers, including members of the Indena senior management team, attended the training.  CONTINUE →

Who’s your PCQI?

By Loren Israelsen, President, United Natural Products Alliance

If I were to ask, “Who is your PCQI?” (Preventive Controls Qualified Individual), there would be three typical responses:

1. What is PCQI?
2. I don’t know; I’ll ask around and get back to you.
3. Yes, we do have a PCQI (BTW: PCQI is a person, not a thing!).

If an FDA investigator or a major customer were to ask this question of you or your staff, then what? I confess, it took me a while to get the acronym and the concept of PCQI straight in my head, so if that is your situation, you are not alone.

What’s a PCQI?

So, what (remember, it is a “who”) is PCQI?

Preventive Controls for Human Foods is one of seven provisions of the Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, which was signed into law by President Obama on January 4, 2011. According to the Food and Drug Administration (FDA), FSMA aims to “ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.”  CONTINUE →

An introduction to Larisa Pavlick, UNPA’s VP, Global Regulatory & Compliance

By Larisa Pavlick, UNPA VP, Global Regulatory & Compliance

Welcome to 2017! I am excited and honored to join the UNPA team and am eager to get to know all of our members and to help you with your compliance needs.

Who am I?

I am joining you with 12 years of dietary supplement industry experience, plus nearly eight years at the Food and Drug Administration as an Investigator. At FDA, I primarily conducted dietary supplement inspections and investigations within the Denver District, covering Utah, Colorado, Wyoming and New Mexico, and internationally.

While working in the dietary supplement industry, I learned the full product-development cycle, beginning from the initial concept, into research and development to the qualification of suppliers, raw material purchasing, manufacturing operations, all the way through to finished product release and distribution. CONTINUE →

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