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NDI Workshop Audio-PPT Package -
NDI Workshop Audio-PPT Package

The complete proceedings from UNPA’s NDI Guidance II and Substances Generally Recognized as Safe Workshop


Now available! The complete audio files and synchronized PowerPoint presentations as well as the separate PPT slides from the Sept. 8, 2016, workshop held in Salt Lake City—the industry’s first deep, comprehensive dive into the 2016 revised draft guidance issued by the Food and Drug Administration on Aug. 11, 2016.

 

You’ll also receive a hard copy of the 160-page accompanying workbook that is referenced throughout the workshop and includes a treasure trove of documents related to the guidance.


UNPA members: Use the coupon code "NDI" to get this series for $295. NOTE: You must register/create an account to apply a "coupon" discount and/or complete your purchase!


The nine audio/PPT files are available in MP4 files and the separate eight PPT files are presented as PDFs and will be made available to you upon completion of your purchase; the hard copy spiral-bound workbook will be mailed to you via USPS.


This one-day conference provided highly pertinent and actionable information on the following aspects of the NDI guidance:

  • A detailed analysis of the major issues and concerns with the 2016 guidance

o   Cost analysis and impact

o   Chemical alteration & manufacturing changes

o   Pre-DSHEA ingredients vs. NDIs

o   Nanotechnology

o   Synthetic botanicals

o   Is GRAS a viable workaround?

o   Due process & enforcement

  • The full presentation and two Q&A sessions with FDA’s Cara Welch
  • A new analysis of market size and cost implications of the guidance
  • Review of two key product categories: probiotics and astaxanthin
  • Results of real-time audience polling

 

This package includes all audio and PowerPoint from the following presentations:

 

1. Welcome & Introduction (11:53)

Loren Israelsen, President, United Natural Products Alliance

2. Opening Comments (8:37)

Sean Reyes, Utah Attorney General

3. The Revised NDI Guidance: Review & Analysis (1:21:52)

Loren Israelsen, President, United Natural Products Alliance

4. Manufacturing Changes & Chemical Alteration: How Old Became New (23:15)

Ashish Talati, Member, Amin Talati & Upadhye

5. The 2016 Revised FDA Guidance: FDA’s Rationale (1:23:58)

Cara Welch, Senior Advisor, Office of Dietary Supplement Programs, Food and Drug Administration

6. Case Studies (40:46)

NDI Guidance & Probiotics: Implications & Perspectives

Amy B. Smith, Ph.D., Senior Manager, Regulatory Affairs, DuPont Nutrition & Health

Astaxanthin: Synthetic/Natural Issue

Jen Johansen, VP of Quality Affairs, Cyanotech Corp.

7. Dietary Supplement Industry Key Metrics: Step 1 for Economic Impact Analysis (17:26)

Skye Lininger, CEO, Healthnotes Inc.

8. Final Q&A Session with FDA’s Cara Welch (33:05)

Cara Welch, Senior Advisor, Office of Dietary Supplement Programs, Food and Drug Administration, with Loren Israelsen, President, United Natural Products Alliance

9. The Revised NDI Guidance: Review & Analysis II, 

Q&A, Summary and Final Comments (1:24:13)

Loren Israelsen, President, United Natural Products Alliance

 

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