NPA's Welch Speaks at FDA-ORCA Conference

WASHINGTONCara Welch, Ph.D., of the Natural Products Association (NPA) will participate as a speaker at the 15^th annual FDA-OCRA Educational Conference on Thursday, June 7. She will present during the breakout session, "FDA Update on Dietary Supplement Industry: Current Hot Topics and Issues You Need to Know," and moderate another session, "QA/QC Issues for Dietary Supplement Industry."

In the " FDA Update" session, Welch will join Daniel Fabricant, Ph.D., the director of FDA's Dietary Supplement Programs, who will speak about the current focus of his office, top priorities and hot topics, including an update on FDMA initiatives. He also will discuss the draft of the new dietary ingredient (NDI) guidance, import issues, product claims and recent enforcement actions including warning letters, product seizures and criminal cases. Welch will present an industry insider's perspective on these issues and present an update on federal and state legislative challenges.

The QA/QC Issues for Dietary Supplement Industry" will include a discussion of the issues surrounding quality control and quality assurance, including verification testing and laboratory issues. Hear about FDA expectations related to quality functions as well as setting and verifying appropriate ingredient and finished product specifications for quality and contaminants. Learn more about industry challenges in determining what are appropriate specifications for ingredients and finished products, conducting verification testing, ensuring verification testing is being performed under GMPS (good manufacturing practice (GMP)-compliant conditions, whether using internal or contract laboratories, and tips on how to work with, qualify and monitor contract laboratories.

The Educational conference is co-sponsored by FDA and the Orange County Regulatory Affairs Discussion Group (OCRA)  to promote interaction between Los Angeles area professionals and Washington- based FDA personnel. The conference is on June 6 to 7 in Irvine, CA.

Welch, vice president of scientific and regulatory affairs, oversees NPAs quality assurance programs, including the NPA GMP Certification Program. She advises NPA members about regulatory, safety, nutrition and health issues. Additionally, Welch is responsible for assisting natural product industry members to implement policies in response to government initiatives in the regulatory arena, and working with officials in FDA and other agencies whose actions have a direct impact on the natural products industry.

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. NPA science and quality assurance manager Vicki Whitsitt serves on the board of directors as program chairperson. She also will moderate two sessions during this event.

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.