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Dietary Supplement GMP Inspectional Readiness Virtual Conference

FALLS CHURCH, Va., June 11, 2013 /PRNewswire-iReach/ -- Dietary Supplement GMP Inspectional Readiness
A Comprehensive Road Map to 21 CFR 111
**Virtual Conference**
June 20, 2013 — 10:00 a.m. – 3:00 p.m. EDT



For an increasing number of dietary supplement manufacturers, the ominous results of increased FDA scrutiny include lawsuits, seizures, 483s and warning letters. Is your company next?

Learn how to navigate this new era in FDA oversight. Register today for this FDAnews-sponsored, day-long virtual conference providing an in-depth road map to 21 CFR 111. Produced in collaboration with EAS Consulting, the virtual event will be held Thursday, June 20, 10 a.m. –  3 p.m. EDT.

Register today to learn:

  • Why most companies encounter trouble and how to avoid it
  • Best practices related to material reviews, including out-of-specification, deviation and product failure investigations
  • How to avoid escalated FDA responses
  • Strategies for avoiding problematic labs
  • Requirements of the final rules and how they may change
  • The FDA's areas of focus during inspections
  • Controls that prevent adulterated products
  • How to assess the compliance health of your quality system
  • And much more

Actionable Information for Your Company
This virtual seminar will benefit dietary supplement manufacturers and retailers, contract manufacturers, excipient manufacturers, packagers, labelers and distributors, contract labs and specialty pharmaceutical companies.

Advice From Leading Experts
The FDA conducted nearly double the number of facility inspections for dietary supplement firms in 2012 as compared to 2011 and issued some 38 warning letters. This event is a must for quality assurance/quality control managers, directors and VPs, regulatory affairs managers, production/packaging and laboratory management, operations managers and VPs, legal counsel and company presidents/CEOs.

10:00 a.m. – 10:15 a.m.
Introduction - 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 - Bob Mehta, Senior Consultant

11:00 a.m. – 11:45 a.m.
How to Perform Thorough Material Reviews and OOS Investigations - Bill Ment, Senior Advisor for Drug/Dietary Supplement Audit Services

11:45 am - 12:00 pm         

12:00 pm - 12:45 pm
How to Properly Respond to 483s and Warning Letters - Bruce Elsner, Senior Consultant

12:45 pm - 1:45 pm

1:45 pm - 2:30 pm
Dietary Supplement Contract Laboratories: Requirements, Selection and Qualification - Dr. Tara Couch, Consultant

2:30 pm – 3:00 pm
Closing Comments and Adjournment - Dean Cirotta, President and COO, EAS

Here's How It Works
Twenty-four hours prior to the broadcast, attendees will receive all presentations.

Then just log on to the website provided in your registration confirmation. And relax. That's all there is to it. You will see and hear the virtual conference in its entirety including all audience questions asked that day. Please remember, sessions are pre-recorded and you cannot have new questions addressed.

Who Will Benefit
Every marketing, advertising and communications specialist in your organization is a candidate to participate in this Virtual Conference. So are general and outside counsel, regulatory and compliance staff, and top management, too. You'll even want to notify the folks you work with at ad, marketing and tech/IT consulting firms. Spread the word!

Conference Details
Dietary Supplement GMP Inspectional Readiness
A Comprehensive Road Map to 21 CFR 111
**Virtual Conference**
June 20, 2013 — 10:00 a.m. – 3:00 p.m. EDT

Tuition: $1,297 per site -- includes virtual conference registration and audio cds and transcripts

3 Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
Fax: 703-538-7676

Media Contact: Jeff Grizzel FDAnews, 703-538-7668,

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