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GMP’s – Understanding and Mastering the Identity Requirements

GMP’s – Understanding and Mastering the Identity Requirements

Register for this important GMP webinar today!

Come join the Natural Products Association on October 11, 2022, for a webinar titled “Understanding and Mastering the Identity Requirements as part of the Good Manufacturing Practices”.

This informational webinar will reveal and discuss issues surrounding the identity definition and portion of the Good Manufacturing laws for the dietary supplement industry. The FDA has issued at least 132 Warning Letters and related materials to companies for potential violations of the “Identity” mandates within the GMP regulations. These violations speak to a knowledge gap in what the FDA wants, and what industry is doing. How these GMP Identity mandates impact and affect the supplement industry may be dependent upon where you are in the supply chain for the ingredient or finished product. The session will feature several experts, including current and former FDA officials, along with leading companies in the industry.

Attendees will:

  • Gain a firm understanding of FDA GMP Regulations surrounding “Identity”.
  • Learn about the best methods for implementing quality analytic and control procedures for Identity Testing and verification.
  • Learn about the different federal identity requirements for product ingredients related to packaging and labeling.
  • Be able to discuss and understand Identity related regulations such as 21 CFR 111.70(b)(1); 21 CFR 111.260(e); (21 CFR 111.95(b)(3)); (21 CFR 111.75(c)(1) and 21 CFR 111.75(d))
  • Gain a greater understanding of FDA Warning Letters focusing on “Identity” and how to avoid these.
  • Be able to discuss how “quality” of a product relates to Identity.

Speakers and Panelists:

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.

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.

Élan M. Sudberg – CEO – Alkemist Laboratories

Élan M. Sudberg is CEO of Alkemist Labs, a passionately committed contract testing laboratory specializing in plant identity, potency, and purity testing to the Food & Beverage, Nutraceutical, and Cosmeceutical Industries. He holds a degree in chemistry from California State University Long Beach, and is on the American Herbal Products Association board of trustees.

 

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. She was also recently appointed as a Member of the Board of Directors for cbdMD. As VP for cbdMD, she directs the company’s research partnerships, clinical trials, advises on regulatory matters, guides new product development and R&D, and provides guidance on good manufacturing practices. Prior to joining cbdMD, Dr. Swift was the Senior Vice President for Scientific & Regulatory Affairs at the Natural Products Association (NPA). In that role, 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. She represented the association on Codex Alimentarius (an international standards organization) and provided guidance on claims reviews, substantiation, and regulatory policy. Before joining NPA, Dr. Swift was the Associate Director for Research and Strategy within the U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs.

Quyen Tien Ph.D. – Office of Compliance. U.S. Food and Drug Administration. Center for Food Safety and Nutrition (FDA-CFSAN)

Quyen Tien is a compliance officer and currently works in the FDA’s Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement. His main area of focus is in the regulation of dietary supplements. As a Compliance Officer, he is responsible for reviewing and evaluating evidence collected during inspections and assisting with determining whether manufacturers and distributors meet FDA laws and regulations for dietary supplements and making recommendations to support administrative or legal actions against firms for non-compliance of FDA laws and regulations.

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.

When:

Tuesday, October 11, 2022 at 2:00pm Eastern.

Price:

NPA Members – $99

Non-NPA Members – $299

Click here to register.