Category Archives: Meetings and Seminars

Preventive Controls Qualified Individual (PCQI)

I am now a Preventive Controls Qualified Individual, thanks to UNPA’s PCQI training class last week.

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!

2017 Rocky Mountain Dietary Supplement Forum – October 10-11 Boulder, CO

2017 Rocky Mountain Dietary Supplement Forum – October 10-11 Boulder, CO – dates and agenda announced.

Rocky Mountain Dietary Supplement Forum
Rocky Mountain – fall aspen leaves.

New Avenues for the Dietary Supplement Industry

Tuesday, October 10 & Wednesday, October 11, 2017
Hotel Boulderado
2115 13th Street
Boulder, Colorado 80302
United States

303-442-4344

 

 

UNPA NDI III: Roadmap to a Viable NDI Policy

UNPA NDI III Conference

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.

CONFERENCE FACULTY

  • Loren Israelsen, President, UNPA
  • Susan Winkler, Chief Risk Management Officer, Leavitt Partners
  • Jim Thomas, Program Director, ETC Group
  • Larisa Pavlick, VP, Regulatory & Compliance, UNPA
  • Marian Boardley, Independent Consultant
  • Skye Lininger, CEO, Healthnotes Inc.

…plus others to be announced

To view/download speaker bios, click here.

REGISTRATION

EARLY BIRD REGISTRATION: Save $100 until Dec. 31, 2016!

Regular registration: $795. $895

UNPA member registration: $525. $625

SupplySide West Workshop: Evaluating and Partnering with Contract Labs

SSW2016logo

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

See http://west.supplysideshow.com/schedule/#/viewEvent/bb49164ebdcc410ea9b41585fb26bfa4/wrk/day/-1

Sizing up the Dark Side: An overview of the NBJ Dark Issue

Date/Time: March 30, 2016, 2:00pm ET / 12:00 MT

Cost: $95

Description:

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:

Steve Mister
President
Council for Responsible
Nutrition
Todd Harrison
Supplements Lawyer
Risa Schulman
Science Consultant
Tap~Root
Marian Boardley
GMP Specialist

Bring questions!

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.

2016 Rocky Mountain Dietary Supplement Forum (Sept 15-16)

RMDSF-2016

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

To register, go to www.regonline.com/rmdsf2016

We look forward to seeing you this fall!”

Save the Date:  September 15-16, 2016

Hotel Boulderado, Boulder, Colorado

FDA: Preliminary FY 2015 483 Data at Rocky Mountain DS Forum

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.

FY 2015 Form 483 preliminary

Note: there are a total of 11 CFR sections listed above (as presented by FDA representatives)