This educational and informative webinar will review and inform the attendees about the Food Safety Modernization Act, the related Foreign Supplier Verification Program and how Third-Party Certifications fit in for the Dietary Supplements Industry.
In recent times, there have been over 150 recent Warning Letters and actions undertaken by the FDA. These actions are specifically related to the Foreign Supplier Verification program (FSVP). This speaks to the need for education and guidance as to what the FDA is expecting and how to set up a quality system, while being compliant with Federal and other regulations.
Speakers:
Daniel Fabricant, Ph.D. – President and CEO – NPA
Daniel Fabricant, Ph.D. is CEO and President of the Natural Products Association (NPA), the nation’s largest and oldest trade organization representing the natural products industry, including dietary supplements, foods, personal care products and more. Most recently, Dr. Fabricant served as the Director of the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA), where he directed agency policy, public affairs and regulatory action regarding regulation of the dietary supplement industry for more than three years. While with the agency, he successfully navigated the large, heavily-matrixed government organizational structure to bring life to a regulatory function that was non-existent for almost 20 years.
Douglas S. Kalman, Ph.D., RD, FACN – SVP, Scientific and Regulatory Affairs – NPA
Dr. Kalman is the Senior Vice President of Scientific and Regulatory Affairs for The Natural Products Association (NPA). Prior to joining the NPA, Dr. Kalman was the VP of Scientific Affairs for Nutrasource, a nutrition-centric Contract Research & Service Organization. In addition, Dr. Kalman is currently Faculty at the Dr. Kiran C. Patel College of Osteopathic Medicine at Nova Southeastern University. Prior to Nutrasource, Dr. Kalman served as Research Director and Investigator at Miami Research Associates/QPS (18-years). He is a co-founder of The International Society of Sports Nutrition. Dr. Kalman has been involved in over 350 clinical trials and projects within the pharmaceutical, medical and exercise – nutrition fields.
Sibyl Swift, Ph.D. – Vice President Scientific and Regulatory Affairs – cbdMD
Sibyl Swift, Ph.D. is the Vice President for Scientific & Regulatory Affairs for cbdMD and the co-chair of cbdMD Therapeutics. As VP for cbdMD, she directs the company’s research partnerships, clinical trials, advises on regulatory matters and provides guidance on good manufacturing practices. Prior to joining cbdMD, Dr. Swift was the Senior Vice President for Scientific & Regulatory Affairs at NPA. Dr. Swift was responsible for the development and implementation of the association’s education, regulatory, and compliance programs and effort, such as the Supplement Safety and Compliance Initiative (SSCI), the NPA Natural Standard, and others.
Robert Durkin, Esq. – FDA and Healthcare Practices. Of Counsel to Arnall Golden Gregory, LLP
Bob joins AGG as of counsel in the firm’s FDA and Healthcare practices, and is a member of the Dietary Supplements industry team. As a former acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP) in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), he brings a wealth of knowledge and insight to his legal practice. Just prior to joining ODSP, Bob was the acting Director of CFSAN’s Food Defense Staff. In this role, Bob led a dedicated group of professionals whose duty it was to determine the best regulatory strategies to help protect our nation’s food supply from intentional contamination.
Julie Ann Wagner Esq. – Managing Counsel, Global Regulatory Affairs – Glanbia Performance Nutrition
Julie Ann Wagner is an accomplished marketer, food scientist and civil litigator with 24 years of experience in both an in-house corporate legal department and law firm setting. She has protected the reputation of almost two dozen of Fortune’s Top 300 Companies concerning their consumer products and sales practices around the world. Julie was instrumental in fostering strong brand loyalty and favorable public opinion through crafting effective marketing messages and exceptional regulatory legal guidance during the development, manufacture and sale of safe and effective consumer products.
Tom Dubinski – VP, Quality Systems – Arizona Nutritionals ANS®
Tom Dubinski is the Vice President of Quality Systems at Arizona Nutritional Supplements and has been with the company for 15 years. He has held positions across all aspects of the ANS quality groups including Lab, Quality Control, and Quality Assurance leadership roles. Tom is integral to implementing and sustaining efficient quality systems across multiple facilities to deliver safe, quality products that meet customer and FDA expectations. Along with his ANS experience, Tom has another 5 years of food and beverage manufacturing experience.
Josh P. Grauso – Operations Manager, Supplier Quality Audits & Certifications – UL
As a senior member of the UL HBW leadership team, Josh works with retailers, brands, grocery, manufacturing organizations and other relative stakeholders to develop, implement and oversee professional 3rd party store, facility and supplier assessment programs related to industry standards for quality, food safety and cGMP compliance. In his current role, Josh has overall accountability for the leadership of the client, technical and field services related to UL’s Supplier Quality Audits & Certifications programs.
Katie Banaszewki – Director of Quality – NOW®
During her tenure at NOW, Katie has led the development and implementation of a routine pesticide residue monitoring program and plays an integral role in growing the company’s analytical capabilities. Katie focuses on exploring new scientific approaches to analytical challenges and her areas of expertise are mass spectrometry and elemental analysis. In her current role, Katie focuses on recent issues within the dietary supplement industry and ensures NOW remains the industry leader in holding high quality standards. Prior to joining NOW, Katie spent 5 years at the Institute for Food Safety and Health.
Siobhan Taylor – National Expert – Dietary Supplements – FDA
Siobhan Taylor is the current FDA National Expert for Dietary Supplements and is geographically based out of the Denver District Office. She joined the Food and Drug Administration, Office of Regulatory Affairs (ORA) as an Investigator in 2015 in the San Francisco District. Since then, she has performed inspections both domestic and foreign for the San Francisco District Office and the Denver District Office and was promoted to the Food Specialist position in Denver District in June 2020. In June 2022, Siobhan was named the FDA National Expert for Dietary Supplements. She has extensive experience in manufacturing, processing, packaging, and distributor type dietary supplement inspections in a variety of dosage forms and has trained FDA Investigators across the country on how to conduct dietary supplement inspections
When:
Wednesday, June 29, 2022 at 2:00pm Eastern.
Price:
NPA Members – $99
Non-NPA Members – $299
