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: ___________________________________________________________________________________ NAME (Last, First) ___________________________________________________________________________ ______________________________________________________ POSITION ___________________________________________________________________________ ______________________________________________________ ORGANIZATION ___________________________________________________________________________ ______________________________________________________ ADDRESS ___________________________________________________________________________ ______________________________________________________ CITY ___________________________________________________________________________ ______________________________________________________ STATE ZIP PHONE E-MAIL Payment Method: Check: Payable to FDACG. Note "DS Forum" on the check and send to FDACG address listed above Credit Card: Visa MasterCard Discover ___________________________________________________________________________ _______________ CREDIT CARD NUMBER EXPIRATION DATE ___________________________________________________________________________ _____________________________________________________ SIGNATURE OF CARDHOLDER