How to Effectively Work with FDA Rocky Mountain Dietary Supplement Forum presents

Rocky Mountain Dietary Supplement Forum
presents
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
Thursday, September 12, 2013
8:00 am–8:30 am
Registration and continental breakfast
8:30 am–9:45 am
What Own-Label Distributors Need to Know – and Other Current Agency
Topics
Dan Fabricant, Director, Division of Dietary Supplements Program, FDA
9:45 am–10:45 am
An Industry Response to FDA’s Recent Perspectives on DSHEA
Compliance
Loren Israelson, Executive Director, UNPA
10:45 am–11:00 am BREAK
11:00 am–12:00 pm Energy Drinks – Dietary Supplement or Food?
Justin Prochnow, Shareholder, Greenberg Traurig LLP
12:00 pm–1:00 pm
LUNCH
1:00 pm-2:30 pm
Industry Panel Shares Their Experiences with FDA
Randy Giboney, President, Western Botanicals
Dino Guglielmelli, President and CEO, Creation’s Garden® Natural Products
Dean Kramer, VP of Operations, Ortho Molecular Products
2:30 pm-2:45 pm
BREAK
2:45 pm-3:45 pm
Association Executives’ Insights on FDA
Cara Welch, Ph.D., Senior VP of Scientific and Regulatory Affairs, Natural
Products Association
Roy Upton, Founder and Executive Director, American Herbal Pharmacopoeia
3:45 pm-5:00 pm
Identity Testing and Other Key Laboratory Issues
James Neal-Kababick, Founder & Director, Flora Research Laboratories
5:00 pm – 7:00 pm
RECEPTION
Friday, September 13, 2013
7:30 am-8:00 am
Continental breakfast
8:00 am-12:00 pm
FDA Denver District Panel
Howard Manresa, Director, Compliance Branch; Nancy Schmidt, Compliance
Officer; and Larisa Pavlick, Consumer Safety Officer
12:00 pm-1:00 pm
LUNCH
1:00 pm-1:45 pm
The Top Five Things You Need to Know About Ingredients
Jim Lassiter, President and COO, Ingredient Identity
1:45 pm-2:30 pm
The OTHER Regulations That Affect Your Business in Big Ways
Shelly Maifarth, FDA Compliance Group and former FDA Compliance Officer
2:30 pm-3:15 pm
How to Effectively Interact with FDA
Martina LaGrange, FDA Compliance Group and former FDA Investigator
3:15 pm
Final questions and adjourn
Sponsors
The
Matthews
Group
The Workshop is being held at:
Hotel Boulderado, 2115 13th Street, Boulder, CO 80302
(303) 442-4344; (800)-433-4344
www.boulderado.com
Our Group Room Rate is $189 – when calling for reservations, please ask for Booking Number
12396. Email: [email protected]
To register, either call or fill out the information below and fax to 303-9540545
Registration
Attn: Evette Shileny, FDA Compliance Group (FDACG)
P.O. Box 574
Broomfield, CO 80038
Tel: (303) 887-6922/ Fax: (303) 954-0545
Registration Fees:
Early Bird - $995
Regular - $1095
# of Attendees
Fees
______ x (registration price) = ________
***Early Bird Rate expires 8/1/2013***
Please complete the following information and fax to 303-954-0545:
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Check: Payable to FDACG. Note "DS Forum" on the check and send to FDACG address
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