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Two leading experts will participate in a panel session about key regulatory issues at the FDA-OCRA Educational Conference on June 13.
June 11, 2013
2 Min Read
Two leading experts from the Natural Products Association (NPA) will participate in a panel session about key regulatory issues at the 16th Annual FDA-OCRA Educational Conference on Thursday, June 13. Cara Welch, Ph.D., senior vice president of scientific and regulatory affairs, and Vicki Whitsitt, scientific and regulatory affairs manager, join Daniel Fabricant, Ph.D., director of the division of dietary supplement programs for the Food and Drug Administration (FDA), and Michael McGuffin, president of the American Herbal Products Association, during the breakout session, "CFSAN and Industry Update." Register to attend at ocra-dg.org.
The Orange County Regulatory Affairs Discussion Group (OCRA) is a nonprofit volunteer organization made up of regulatory affairs professionals in Southern California who are interested in educational programs and networking opportunities. Whitsitt serves on the board of directors as president-elect.
Event details:
Educational conference co-sponsored by the FDA to promote interaction between Los Angeles area professionals and Washington, D.C.,-based FDA personnel
June 12-13
Irvine Marriott, 18000 Von Karman Avenue, Irvine, Calif.
Open to all attendees; register online at ocra-dg.org
Session details:
“CFSAN and Industry Update”
June 13 at 8 a.m. PST
This session will feature an update from the FDA about industry hot topics, including the agency’s current regulatory priorities. In addition, the experts from the two industry associations will address the challenges facing dietary supplement companies both on Capitol Hill and on the regulatory front. While Good Manufacturing Practices (GMPs) continue to be at the forefront of FDA activities, it’s not just about GMPs – speakers also will touch on topics such as Adverse Event Reporting (AER), the draft New Dietary Ingredient (NDI) guidance, proposed rules under the Food Safety Modernization Act (FSMA), imports/exports of supplement ingredients, the challenge of adulterated ingredients, and more.
NPA launched a GMP certification program in 1999, the first third-party GMP certification program for the manufacturing of dietary supplements and ingredients. More than 70 companies have achieved certification. In addition, more than 1,000 participants from more than 600 companies have attended an NPA GMP education session. Find out more at NPAinfo.org/GMP.
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