Dietary Supplement GMP Inspectional Readiness VC Agenda

Dietary Supplement GMP Inspectional Readiness
A Comprehensive Road Map To 21 CFR 111
An FDAnews Virtual Conference
Thursday, June 20, 2013 • 10:00 a.m. – 3:00 p.m. EDT

10:00 a.m. – 10:15 a.m.

Introduction to the Virtual Conference - Dean Cirotta, President and COO

10:15 a.m. – 11:00 a.m.

Update on Dietary Supplement GMP Compliance Rules in the Face of FDA Scrutiny
cGMP requirements from the 16 Subparts of the 21 CFR Part 111 regulations are not accurately followed by manufacturers, packagers, labelers, and holders of dietary supplements. When manufacturers are audited by the FDA, they may be at risk of receiving warning letters. Adulterated products are marketed and sold to the public and this poses a risk to consumer safety. Based on FDA’s recent inspection trends, the most common findings given to dietary supplement companies will be discussed and clarification provided to mitigate compliance risk.

Attendees will learn:

  • Insight into FDA’s areas of focus and concerns during inspection.
  • The most common GMP violations in supplement manufacturing.
  • How to assess the compliance health of their quality system.
  • The best practices on where to make necessary changes to their manufacturing process to mitigate compliance and quality risks.

Bob Mehta, Senior Consultant

11:00 a.m. – 11:45 a.m.

How to Perform Thorough Material Reviews and OOS Investigations
21 CFR Part 111 has numerous references to performing material reviews throughout the regulation indicating the importance of this topic. FDA wants evidence to demonstrate that dietary supplement companies are properly investigating and handling problematic batches and situations that could impact product quality. This has been a target area for years by FDA in the pharmaceutical industry and there is evidence that it is becoming an increasing target by the regulators in the dietary supplement industry as well. This presentation will provide information that will help ensure companies adequately perform and document material reviews, including out-of-specification, deviation, and product failure investigations.

Attendees will learn:

  • The 5 reasons QC must make a material review and disposition decision
  • Best practices for performing OOS and other types of material reviews
  • How to interpret FDA 483 citations to avoid making the same mistake

Bill Ment, Senior Advisor for Drug/Dietary Supplement Audit Services

11:45 a.m. – 12:00 p.m.


12:00 p.m. – 12:45 p.m.

How to Properly Respond to 483s and Warning Letters
Failure to respond properly inevitably leads to an escalated and high impact response from the FDA (e.g., warning letters commonly follow a poor response to Form 483 observations and a consent decree or other severe FDA action commonly follows what the FDA considers to be an inadequate response to a warning letter). Following the guidance in this presentation will largely assure the FDA that your company is committed to achieving regulatory compliance, that you understand how to properly address the stated observations and consequently will greatly minimize the risk of further escalated responses from the FDA.

Attendees will learn:

  • Top 5 reasons for escalated FDA enforcement actions
  • 7 recommendations for an effective 483 response
  • 22 commonly cited deficiencies in compliance with GMP

Bruce Elsner, Senior Consultant

12:45 p.m. – 1:45 p.m.


1:45 p.m. – 2:30 p.m.

Dietary Supplement Contract Laboratories: Requirements, Selection and Qualification
A contract laboratory is an essential partner of a dietary supplement manufacturer. The data generated at the laboratory ensures the quality of the dietary supplement product by demonstrating it meets the specifications for identity, purity, strength, composition, and absence of possible contaminants dictated in 21 CFR 111. However, using and understanding a contract laboratory can be challenging particularly when the services being provided are beyond the manufacturer capabilities. In this presentation, attendees will learn how laboratory regulatory requirements are fulfilled and learn some of the basic functions of a successful laboratory to help select a qualified contract laboratory.

Attendees will learn:

  • The 5 key musts to be FDA compliant for laboratory operations
  • The 4 written procedures necessary for optimal compliance for 21 CFR subpart J
  • Best practices to effectively select a contract laboratory

Dr. Tara Couch, Consultant

2:30 p.m. – 3:00 p.m.

Closing Comments and Adjournment - Dean Cirotta, President and COO, EAS