Dr. Cara Welch of the Natural Products Association (NPA http://www.npainfo.org/) will participate as a speaker at the 14th Annual FDA-OCRA Educational Conference on Thursday, June 9. She will moderate two sessions, “FDA Update” and “Lessons from the Field,” and serve as a panelist on another session, “Issues and Best Practices in Quality Assurance and GMP Compliance.” Dr. Welch oversees NPA’s quality assurance programs, including the NPA GMP Certification Program <http://www.npainfo.org/index.php?submenu=GMPcert&src=gendocs&ref=NPAGMPCertification&category=Quality>. Get more information at http://www.ocra-dg.org/.
The Orange County Regulatory Affairs Discussion Group (OCRA) is a nonprofit volunteer organization made up of regulatory affairs professionals from the Southern California area 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.
* Educational conference co-sponsored by the Food and Drug Administration
(FDA) to promote interaction between Los Angeles area professionals and
Washington, D.C. based FDA personnel
* June 8-9
* Irvine Marriott, 18000 Von Karman Avenue, Irvine, Calif.
* Open to all attendees; register online at http://www.ocra-dg.org/
* “FDA Update”
* June 9 at 9 a.m.
* Speakers will discuss current FDA activities related to the dietary supplement industry, including current agency priorities, recent industry related activities, and enforcement actions related to product and ingredient contamination.
* “Lessons from the Field”
* June 9 at 10:30 a.m.
* The FDA good manufacturing practices (GMPs) for dietary supplements have been in place for nearly four years. To date, FDA has conducted more than 100 GMP inspections. FDA will discuss their current inspection priorities and get feedback on their inspections. Attendees will learn how to handle visits from the FDA, appropriate follow-up to Form 483s, and strategies to avoid potential warning letters and other enforcement action.
* “Issues and Best Practices in Quality Assurance and GMP Compliance”
* June 9 at 2:45 p.m.
* An interactive panel talks about current industry issues and best practices related to quality assurance and GMP operations. Following their discussion, panelists will answer questions from the audience.
Dr. Welch is vice president of scientific and regulatory affairs for NPA. She advises NPA members on regulatory, safety, nutrition and health issues. Additionally, Dr. 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 the FDA and other agencies whose actions have a direct impact on the natural products industry.
NPA launched a GMP certification program in 1999, the first third-party GMP certification program for the manufacturing of dietary supplements and ingredients. Nearly 70 companies have achieved certification. Learn more at www.npainfo.org/gmp.
Natural Products Association
The Natural Products Association (NPA), founded in 1936, is the largest and oldest nonprofit organization dedicated to the natural products industry. NPA represents over 1,900 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. As the leading voice of the natural products industry, the NPA’s mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health, and for the rights of retailers and suppliers to sell these products. Visit http://www.npainfo.org/.