How to prevent your dietary supplement analytical laboratory from becoming a regulatory compliance risk

Photo Copyright Brian Parkin 2013

One and a Half day In-Person Seminar

Course Description:

The cost of non-compliance with regulatory standards within the dietary supplement industry has already been big. Several firms have suffered irreparable damage to their reputations for failing to implement and maintain strong laboratory compliance and testing programs. Make sure that your organization’s laboratory compliance program is effective and tailor-made in light of the key risk factors within your organization.

This seminar will provide an overview of the importance of the role of the laboratory within your larger quality organization in implementing and maintaining a strong testing compliance program. We’ll review enforcement action case studies and discuss how they might have been prevented. We’ll also review key internal controls that can help prevent laboratory non-compliance becoming a problem during an FDA inspection.


Location: Houston, TX

Date: Thursday, March 20, 2014 and Friday, March 21, 2014

2013 Rocky Mountain Dietary Supplement Forum

If you are looking for information about the 2015 Rocky Mountain Dietary Supplement forum please click here

Rocky Mountain Dietary Supplement Forum

How to Effectively Work with FDA

A two-day seminar to learn directly from industry experts

September 12-13, 2013      Boulder, Colorado

  • Learn how to dramatically change the outcome of your inspection with the Agency
  • Hear from FDA Denver District representatives about what they expect during an inspection
  • Interact with other industry professionals who are facing the same challenges you are

Contact Marian for more details.


AHPA’s cGMP Compliance Series: cGMP Change Control

Thursday, June 20, 2013

1- 3 p.m. EDT


Member: $195 Nonmember: $495


Marian Boardley, Marian Boardley Consulting

Staci Eisner, Cortex Scientific Botanicals

Stefan Gafner, Tom’s of Maine

Anthony Young, Kleinfeld, Kaplan & Becker and AHPA General Counsel



Who should attend: QA/QC personnel, Lab managers, technicians, Operations, R&D staff, New product development, and formulation personnel

Register today!


8630 Fenton St.,

Ste. 918

Silver Spring,

MD 20910

 AHPA’s cGMP Compliance Series


“Best Practices” for cGMP

Change Control

cGMP compliance information for

dietary supplement businesses

Thursday, June 20, 2013

1 – 3 p.m. EDT

Change control is the process of implementing changes to cGMP-related operations and other business systems in a manner that ensures effectiveness and continued compliance.

Change control can be applied to any business system, but in a cGMP context it can be applied to:

  • Products (formulas, labels, etc.)
  • Processes (manufacturing processes, test methods, etc.)
  • Equipment and facilities (rooms, utility systems, process equipment, test equipment, instruments, utensils)
  • Components and supplies, and vendors thereof
  • Software, spreadsheets
  • Personnel
  • Documents (SOPs, MMRs, specification documents, forms, logs, etc.)

Some changes are routine, such as training new personnel, updating a document, or replacing a simple test instrument such as a thermometer; these changes can be controlled through the establishment of an SOP for each circumstance.
Other changes are not routine, such as installing new major manufacturing equipment or significantly changing a manufacturing process, and need to be evaluated on a case-by-case basis.

During this two-hour teleseminar, which includes a dedicated Q&A session, learn from experts about how to implement and manage change control in compliance with 21 CFR 111.



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Prevent Your Dietary Supplement Lab from Becoming a Compliance Risk (PerkinElmer INnovation Tour 2013)

I will be speaking in Iselin, NJ and Portland, Oregon during the upcoming PerkinElmer tour.

Evidence from recent FDA Warning Letters and 483’s issued to dietary supplement firms under current good manufacturing practice regulations (21 CFR 111 cGMP’s) indicates that FDA is stepping up its focus on laboratories and testing.  This presentation outlines the common laboratory compliance problems FDA is finding during inspections, and shows how those issues can easily escalate into Warning Letters if not properly corrected.

Details are here:

Hope to see you there!

FDA Releases New TurboEIR (483) Data

I’m pleased to announce that FDA has posted the Turbo EIR data for inspection observations (483’s) for FY 2011 & FY 2012.

I will be working on some new charts in the next couple weeks, but here is some preliminary data.  As you can see, ‘Component –  verify identity, dietary ingredient’ — aka 21 CFR 111.75(a)(1)(i) — became an even bigger issue during 2012 inspections than in previous years, and now leads as the most cited item for all years combined (for inspections under 21 CFR 111 GMP’s.)  Having proper SOP’s in place for product complaints and QC operations remains a big priority, along with complete specifications/MMR/BPR and supplier qualification.

There were a total of 1964 21 CFR 111 observations entered into the FDA TurboEIR system in 2012, compared with 1328 (2011); 631 (2010); 130 (2009).

Top 483 observations FY 2008 – 2012 total:

Total Observations
Component –  verify identity, dietary ingredient 106
Specifications – identity, purity, strength, composition 95
Written procedures – product complaint 93
Written procedures – quality control operations 91
Component – qualify supplier 80
Batch record – complete 78
Specifications met – verify; finished batch 71
Master manufacturing record – unique formulation 67
Master manufacturing record – each batch 66
Written procedures – holding 54
Specifications-component purity, strength, composition 54

See for more information about this data and how it is gathered.

Rocky Mountain Dietary Supplement Forum – Sept 13-14 2012, Boulder Colo.

The Rocky Mountain Dietary Supplement Forum held a successful 1.5 day seminar in Boulder, Colorado, September 13-14.  The event hosted several speakers and a panel composed of industry executives and quality managers who spoke about their firms’ experiences during FDA inspections.  Delegates heard from FDA Denver District representatives what they expect during an inspection, and learned how to dramatically change the outcome of their inspection.  Attendees received step-by-step instructions and templates on how to respond to 483s and Warning Letters.  We also heard about record keeping, labeling, and testing issues frequently found during inspections and reviews at dietary supplement manufacturers and distributors.  The meeting gave speakers and guests alike the opportunity to interact with other industry professionals who are facing the same challenges.  The organizers hope that the forum will become an annual event. [see update]

Speakers: Nancy Schmidt, Compliance Officer, and Devin Koontz, Public Affairs Specialist, Denver District FDA;  Justin and Jim Prochnow, Shareholders, Greenberg Traurig LLP; James Neal-Kababick, Founder & Director, Flora Research Laboratories; Cindy Beehner, Owner, QSD Consulting; Mollie Kober, Auditor, and Lisa Thomas, Business Unit Manager, Dietary Supplements and Sports Nutrition, NSF International; Shelly Maifarth and Martina LaGrange, FDA Compliance Group, LLC; Marian Boardley.  Industry Panel: David Hinton, President & CEO, Nelson Bach (USA) ; Doug Robertson, Director, Quality & Compliance, Rhema Health Products Ltd.; Teressa Street, Director of Quality, 4Life Research.

The event was sponsored by Nu Skin Enterprises and NSF.

Press Coverage:

Good 483 responses can squelch warning letters

Have a game plan for GMP inspections, experts say

GMPs: Lack of records starting to sound like broken record

Keep CEOs on short leash during GMP inspections, experts say

Rocky Mountain Dietary Supplement Forum