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GMP’s – Understanding and Mastering the Specification Requirements

GMP’s – Understanding and Mastering the Specification Requirements

Register for this important GMP webinar today!

Attendees will:

  • Gain a firm understanding of FDA GMP Regulations surrounding “specifications”.
  • Learn about best methods in implementing quality analytic and control procedures for setting specifications.
  • See the nuances of understanding specifications may not be uniform across all products developed.
  • Gain a greater understanding of FDA Warning Letters that focus on “specifications” and how to avoid these.
  • Gain an understanding of how important specifications are for product integrity.
  • Be better able to converse about Good Manufacturing Practices and the specification mandates.

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.

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.

Dr. Joseph Betz, Ph.D. – Acting Director of the Office of Dietary Supplements (ODS) – NIH

Joseph M. Betz, Ph.D., is Acting Director of the Office of Dietary Supplements (ODS) at the National Institutes of Health. From 2002 to 2018, he was Director of the ODS Analytical Methods and Reference Materials Program. This NIH program is congressionally mandated and is responsible for supporting the development and validation of analytical methods and reference materials for dietary supplements (DS).

Haijing Hu, Ph.D. – Chief, Regulations Implementation Branch, Office of Dietary Supplement Programs – FDA

Haijing Hu joined the FDA in 2010 and has served in several roles and positions. Her current role is the Chief of the Regulations Implementation Branch (RIB) in the Office of Dietary Supplement Programs (ODPS) within the Center for Food Safety and Applied Nutrition (CFSAN) at the US Food and Drug and Administration (FDA). She leads a multi-disciplinary team to review industry submissions and inspectional findings on labeling and CGMP compliance. She also works with collaborating FDA offices developing compliance actions and compliance policies.

Andrea Lester – Vice President, Global Quality – Natural Alternatives International, Inc.

Andrea Lester is responsible for development, implementation, and enforcement of the firm’s Quality Management Systems to ensure compliance with Good Manufacturing Practices, regulatory requirements, and customer specifications across the firm’s North American and European operations. Ms. Lester oversees all aspects of Quality Assurance, Quality Control, Document Control, Validation, and Quality Systems. She is a member of the American Society for Quality (ASQ) Food, Drug, and Cosmetic Division and serves on the benchmarking committee for the Supplement Safety and Compliance Initiative (SSCI).

 

When:

Wednesday, September 14, 2022 at 1:30pm Eastern.

Price:

NPA Members – $99

Non-NPA Members – $299

Click here to register.