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GMP Inspection Training: How to Avoid Citations and Prepare for Your Next FDA Inspection

 

June 27-28, 2017 in Provo, Utah

Registration is now open.

View a short video by Larisa Pavlick introducing this training.

Join the United Natural Products Alliance for two intensive days of GMP training that will provide exactly what you need to know before your next FDA GMP inspection or audit, with a focus on the key elements of quality: identity, purity, strength and composition. Taught by former FDA Investigator Larisa Pavlick, UNPA’s VP, Global Regulatory & Compliance, who has been in more than 200 facilities. 

This training will equip your manufacturing, operations, QA/QC, management, purchasing, regulatory and compliance personnel with all the tools and resources they’ll need to handle and respond to your FDA GMP inspections or audits. CONTINUE →

 

UNPA presents PCQI training:

Preventive Controls Workshop for Dietary Supplements

PCQI training for dietary supplement companies


July 17-19 | Hilton Salt Lake City Center | Salt Lake City

This class fulfills the FDA Requirement for a Preventive Controls Qualified Individual (PCQI) under The Food Safety Modernization Act (FSMA) and is limited to 30 participants!

FSPCA Preventative Controls for Dietary Supplements

This UNPA 2.5-day PCQI training course provides exercises specific to dietary supplements. The remainder of the course was developed by the Food Safety Preventive Controls Alliance (FSPCA) and is the “standardized curriculum” recognized by the Food and Drug Administration. Successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual (PCQI).” A PCQI is a professional that can manage a Food Safety Plan at a facility in accordance with FSMA. This person should have successfully completed training in the development and application of risk-based preventive controls.

The course will be led by Larisa Pavlick, UNPA’s VP of Global Regulatory & Compliance, a former FDA investigator, who is a PCQI and has completed PCQI Lead Instructor training through FSPCA.

For event, lodging, travel information and to register: 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 →


2016: The year of the hammer and squeeze

Industry should set a course that strengthens systems, quality and rigor

By Loren Israelsen, President, UNPA

2016 felt like the year of hammer blows and the squeeze play, with the finale the unpredicted win of Donald Trump as president. I count myself among those who close this year pondering the state of affairs globally, nationally and personally.

A number of historians have noted that the changes we see in national opinion, the break up of historic alliances and the flows of displaced peoples and disruptions this creates are well-known patterns. We feel these same forces within our own industry. At its heart, we appear to be in the midst of a great Squeeze. This Squeeze is the flight of stability, a sense of prospects and opportunity of the “middle class” of our industry, who are the rank-and-file ingredient supplier, contract manufacturer and small retailer. Like elsewhere, many have a sinking feeling, while a few are doing spectacularly well. This middle part of our industry is the ballast of the boat and the gyroscope that keeps us balanced. As they are the center point between the consumer and the origin of ingredients, they are feeling the pressures of lower consumer prices but rising costs to meet GMP, quality and global-supply standards.

And then there is the Hammer.  CONTINUE →


 

Featured Video

A Nutrition Crisis

Aug 19, 2016 —Dr. Tieraona Low Dog talks about the untold story of nutritional deficiencies in the United States.

Courtesy of New Hope Network


 

UNPA EVENTS

See the Events page for a complete listing of UNPA educational events. 

New Prop 65 Insurance Coverage

Announcing new Prop 65 insurance coverage for dietary supplements from LifeScienceRisk, a UNPA member. Unlike previous coverage, this is a stand-alone policy that was developed after a careful review of Prop 65 claims and cost of administrative defense and settlements.

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unpa_cis_thumbCOMING SOON: UTAH DIETARY SUPPLEMENT DIRECTORY

UNPA is currently updating its Utah Dietary Supplement Directory, a fact-filled resource for anyone interested in the DS industry in Utah, widely considered the epicenter of DS manufacturing. Available Summer 2017.

Best-in-class liability insurance for best-in-class companies

UNPA is pleased to partner with RT Specialty to offer Platinum Program Product Liability Insurance that offers higher limits and lower premiums for companies that qualify.

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