The course was developed by the Food Safety Preventive Controls Alliance (FSPCA) and is the “standardized curriculum” recognized by the Food and Drug Administration. The class provides training in the development and application of risk-based preventive controls.
A PCQI is a professional that can manage a Food Safety Plan at a food manufacturing or packaging facility in accordance with FSMA (Food Safety Modernization Act) Preventive Controls for Human Food. The class qualified me to:
Understand Good Manufacturing Practices (specifically 21 CFR Part 117) and Prerequisite Programs
Conduct hazard analysis and determine preventive controls
Develop and implement a food safety plan for their production facility
Define process, allergen, sanitation and supply-chain preventive controls
Implement verification, validation, recall and record keeping requirements.
Big thanks to Larisa Pavlick and Kathy Gombas for being such great instructors!
NDI III: Roadmap to a Viable NDI Policy
Thursday, Feb. 9, 2017
Salt Lake City
After all of the reading, review and research, the 2016 NDI guidance comments are in. But what should industry do about serious technical issues and product categories? What can it expect from the incoming administration and FDA?
Join an outstanding faculty at this one-day conference produced by the United Natural Products Alliance (UNPA), which will provide actionable updates on the final piece of the Dietary Supplement Health and Education Act (DSHEA) regulatory legacy, including:
NDI guidance comments
Industry’s place in the new administration
FDA’s 2017 enforcement priorities
Key technical issues, including synthetic botanicals, nanotechnology, probiotics and more
The old dietary ingredients list
A go-forward action plan
To view/download the conference program, click here.
Loren Israelsen, President, UNPA
Susan Winkler, Chief Risk Management Officer, Leavitt Partners
I will be speaking along with 3 other presenters at this workshop on
Wednesday, October 05, 1:30 PM – 4:30 PM
Laboratory testing of ingredients and finished goods is top-of-mind in the natural products industry. Beyond the media coverage of testing methods lie a host of concerns from qualifying and selecting an appropriate laboratory partner to method validation, audits and supply chain integrity. Explore the current state of affairs and join the discussion around how appropriate testing and information sharing throughout the product development process is critical to efficacy and safety.
What should a laboratory audit entail and can a lab meet specific testing needs
The GMP testing requirements and their impact on manufacturers and marketers
Supply chain management and the role of testing throughout the chain
The Dark Issue is the most talked about issue in NBJ history and we’re ready to talk about it some more. Join us March 30 at 2 p.m. eastern standard time for a webinar examining some of the biggest challenges facing the supplement industry. Topics to be discussed include:
Adulteration in the supply chain
Best use of scientific studies
Spiking in sports medicine
GMP violations and FDA Warning Letters
Retailers as gatekeepers
What the industry is doing to hold onto consumer trust
What a new approach to regulation could mean
The first quarterly webinar of 2016 will feature presentations and discussion with:
Council for Responsible
The presentations will be followed by what we expect to be a lively Q&A. The Dark Issue webinar is free to subscribers, or with a purchase of the Black Issue Extended Edition. Or buy a seat for $95.
I encourage everyone involved in the dietary supplement industry to attend this forum, it is second to none at providing up-to-date, accurate, non-biased, non-commercial, practical information on how you can meet your FDA compliance obligations. Previous forums have had lots of great Q&A sessions where you get to learn from members of the audience as well as from the excellent and knowledgeable presenters. The location can’t be beat! – Marian.
The organizers say:
“Based on the successes of the 2012 -2015 Forums, we would like to invite you once again to join us in Boulder, Colorado in 2016.
From FDA representation to industry panels to manufacturing insights, the 2016 program promises to continue our goal of educational excellence for the dietary supplement industry.
Some of this year’s speakers are:
FDA Denver District Panel [invited]
Howard Gurney, Executive Director, USANA Health Sciences
Loren Israelsen, President, UNPA
Joy Joseph, Principal, Joy’s QM System, Inc.
Dean Kramer, President, Provident Nutraceuticals/OMPI
Justin Prochnow, Attorney, Greenberg Traurig LLP
Roy Upton, Executive Director, American Herbal Pharmacopoeia
Based on preliminary FY 2015 data released by FDA’s Denver District at the Rocky Mountain Dietary Supplement Forum in Boulder, Colo. last week, Form-483 citations are down overall for dietary supplement firms, and there has been a shift from focusing on identity testing of ingredients (although this is still a very common and important finding) toward observations related to setting specifications for finished products. This trend continues from FY 2014. Data are preliminary because FY 2015 was not yet closed when the data were gathered (closes Sept 30, 2015). I will be publishing complete FY 2015 figures when they become available from FDA’s website. In the meantime, here is a chart based on last week’s data and historical 483 observations from 2009-2014, ordering is based on preliminary FY 2015 frequency.
Note: there are a total of 11 CFR sections listed above (as presented by FDA representatives)