OCRA Supplements Update: What’s on the Horizon in 2013
Orange County Regulatory Affairs Discussion Group (OCRA)
Wednesday, January 9, 2013
12:30 pm – 5:00 pm
18000 Von Karman, Irvine, CA 92612
Cameron B. Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs and Intellectual Property, Herbalife International of America
Vicki Whitsitt, Manager, Scientific and Regulatory Affairs, Natural Products Association
12:30 – 1:00 p.m.
1:00 – 2:45 p.m.
Industry Update & What’s on the Horizon for 2013
Cara Welch, Ph.D., Vice President, Scientific & Regulatory Affairs, Natural Products Association (NPA)
Michael McGuffin, President, American Herbal Products Association (AHPA)
An industry update on regulatory activities that includes an update on current FDA activities including GMP inspections, GMP challenges with botanical dietary Ingredients & SAERs & a look at what’s ahead in 2013
2:45 – 3:00 p.m.
3:00 – 3:45 p.m.
Testing and Laboratory Challenges
Speaker: Timothy Stewart, Ph.D., Consultant, QSD Consulting Group
Topics to Be Discussed:
1) FDA inspectors have developed and grown from entry level regulation curriculums. The harder questions are coming, how is your firm going to respond?
2) Specifications, raw material and finish product
3) Testing, raw material and finish product
4) Test appropriateness
8) Sampling methods
9) Subset testing
10) What does that mean for your contract operations (manufacturing and laboratory)?
11) Qualified People
12) Corrective Action Reporting
13) OOS/OOT procedure
14) What does that mean for Quality Assurance and Regulatory Departments
3:45 – 4:30 p.m.
When to Call in the Experts
Speaker: Cameron Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs & Intellectual Property, Herbalife International of America
4:30 – 5:00 p.m.
Open Q&A with Speaker Panel
Registration fee includes snacks, parking and access to electronic presentations (if approved by speakers for distribution).
About the Speakers
Michael McGuffin was honored in 2010 for over 20 years of dedicated service, having served as the President of the American Herbal Products Association (AHPA) and a member of the Board of Trustee’s for 10 years prior. He has been active in the herbal industry since 1974, having owned both retail and manufacturing businesses in this field.
A leading expert on dietary supplement regulation, Mr. McGuffin has been published in scholarly and scientific journals, including the Food and Drug Law Journal and Clinical Pharmacology & Therapeutics, and also wrote the highly-lauded publication AHPA’s Annotated Final Rule on Dietary Supplement cGMP (2007). Additionally, Mr. McGuffin served as Managing Editor of AHPA’s Botanical Safety Handbook (1997) and Herbs of Commerce, 2nd edition (2000). He speaks frequently on dietary supplement regulation in the U.S. and abroad.
Mr. McGuffin has represented the herbal industry at state and federal hearings on herbal regulatory issues. He has served as a member of the FDA’s Food Advisory Committee Working Group on Good Manufacturing Practices for Dietary Supplements (1998-99), the FDA’s Food Advisory Committee’s Dietary Supplements Subcommittee (2003-5) and currently serves on California’s Office of Environmental Health Hazard Analysis Food Warning Workgroup and the Advisory Board of the USC School of Pharmacy Regulatory Science Master’s Degree Program. He also serves on the boards of the American Herbal Pharmacopoeia, the American Association of Acupuncture and Oriental Medicine, and United Plant Savers.
Mr. McGuffin was awarded the Cliff Adler “Heart in Business” award in 1994 and the Nutrition Business Journal Award for Efforts on Behalf of Industry in 2004. Mr. McGuffin has been quoted in a variety of news publications such as the New York Times, the Washington Post, U.S. News & World Report and Newsweek and has made appearances on ABC’s Nightline, National Public Radio, and ABC Radio.
Cameron B. Smith, J.D., Senior Director, Regulatory, Government & Industry Affairs & Intellectual Property
Herbalife International of America
Cameron Smith has worked for Herbalife for eleven years and is one of the Company’s in-house attorneys. In addition to managing and protecting the Company’s intellectual property portfolio and handling a range of government-affairs responsibilities, he is the counsel of first resort for regulatory questions about foods, dietary supplements, and cosmetics, as well as product-related advertising and marketing issues. Admitted to practice in California, Louisiana, and Mississippi, Cameron earned his law degree at the University of Mississippi School of Law and his undergraduate degree at the University of Pennsylvania.
Timothy Stewart, Ph.D.,. QSD Consulting Group
Dr. Timothy Stewart is a retired professional athlete who became a scientist from University of Southern California. He has 10 years experience in oncology and chemistry laboratories using both modern instrumentation and classic compendia methods to bring better understanding of regulatory compliance to suppliers, manufacturers and marketers. Timothy has three years of experience with contract manufacturing of dietary supplements. Currently, he speaks, writes papers, audits, and works in a laboratory for the non-prescription drug, medical device, cosmetic, dietary supplement and food industries. He’s a consistent co-author for primary peer reviewed chemistry journals. In his spare time he can be found on the disc-golf course or riding waves in the ocean. You may view his profile at: http://www.linkedin.com/profile/view?id=48693551&trk=hb_tab_pro_top.
Cara Welch, Ph.D., Vice President, , Scientific & Regulatory Affairs Natural Products Association
Dr. Welch assists natural product industry members to implement policies in response to government initiatives in the regulatory and policy arena, and works with members of Congress and their staff, officials in the Food and Drug Administration (FDA), and other agencies whose actions have direct impact on the natural products industry. Additionally, she is responsible for advising association members on regulatory, safety, nutrition and health issues. Finally, she directs strategy development and provides guidance of the NPA Scientific and Regulatory programs, including the association’s Natural Certification for Personal Care and Home Care Products and Dietary Supplement GMP Certification.
Prior to joining the NPA, Dr. Welch studied at the department of Medicinal Chemistry at Rutgers University, under the direction of renowned plant biologist Dr. James E. Simon working on African botanicals and medicinal plants. She also studied with NPA Burton Kallman award winner Dr. Koji Nakanishi through the National Science Foundation’s Research Experience for Undergraduates (REU) award program. She earned her M.S. in Chemistry from the University of Iowa under Dr. James B. Gloer and her B.A. in Chemistry from Dordt College. She is a member of the American Chemical Society, American Society of Pharmacognosy and serves as a peer-reviewer for editorial boards.
$135 OCRA Members
$185 Non Members
(includes OCRA Membership for one year)
$75 Student/Government Rate
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Please submit the online registration form. Mail your check made payable to OCRA to the following address:
Orange County Regulatory Affairs Discussion Group
5319 University Dr., Suite 641, Irvine, CA 92612
Fax: 949-266-8461 or 949-387-9047
OCRA’s non-profit Federal Tax ID# 33-0630455
NOTE: We will ask for a credit card payment for any checks not received by the meeting date
For a refund, please cancel by replying to this email by January 2, 2013.
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Irvine Marriott John Wayne Airport
18000 Von Karman Avenue, Irvine, CA 92612
From OC/John Wayne Airport:
Exit airport on Michelson Drive. Go straight to Von Karman Avenue and turn Left onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Long Beach Airport
or LAX – Los Angeles International Airport:
Take 405 South (San Diego Freeway). Exit Jamboree and turn Right off ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Ontario International Airport:
Take 10 West (San Bernardino Freeway) to the 57 South (Orange Freeway). Take 57 South to the 5 South (Santa Ana Freeway). Take 5 South to the 55 South (Newport Beach Freeway) and then to 405 South (San Diego Freeway). Exit Jamboree, turn Right off ramp. Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Downtown Los Angeles:
Take 5 South (Santa Ana Freeway) to 55 South (Newport Beach Freeway). Take 55 South to 405 South (San Diego Freeway). Exit Jamboree and turn Right off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Diego:
Take 5 North (Santa Ana Freeway) to 405 North (San Diego Freeway). Exit Jamboree and turn Left off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Bernardino/Riverside:
Take 91 West (Riverside Freeway) to 55 South Freeway (Newport Beach Freeway). Take 55 south to 405 South Freeway (San Diego Freeway). Exit Jamboree Road, turn right off ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
It is recommended that you look up driving directions from your own starting point.
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Alt Fax: 949-266-8461