ChromaDex Corporation (CDXC 1.57, +0.07, +4.67%) announced that CEO and Co-Founder Frank Jaksch will participate in a Natural Products INSIDER webinar on Tuesday, December 14 at 2 p.m. EST. The webinar, entitled, "Establishing Identity and Quality Testing Programs for Compliance with the Dietary Supplement cGMPs," will discuss how companies can improve their approach to identity and quality testing for current good manufacturing practice (cGMP) compliance.
Mr. Jaksch will discuss the importance of authenticated reference standards for identity testing. Other featured speakers include Carl Reynolds, senior advisor on dietary supplements at the FDA, who will discuss component regulatory specifications and an overview of FDA expectations, and Cynthia Kradjel, business development manager at Bruker Optics, who will discuss how to develop FT-NIR methods that are fit for purpose.
Participants can register for the webinar at the following website: http://event.on24.com/eventRegistration/prereg/register.jsp?eventid=265144&sessionid=1&key=32B03820DD47F2A1BFC21B8C8FD289DA
The U.S. Food and Drug Administration hold companies that manufacture and distribute dietary supplements in the U.S. responsible for the identity, purity, strength and composition of their product. Manufacturers must establish controls to ensure their product and the raw materials they purchase for production meet these quality standards. However, according to recent FDA reports, one-third of compliance inspections have found issues with recordkeeping, manufacturing, quality-control plans, and lack of identity and end-product testing.
About Frank Jaksch
Frank Jaksch is the President, CEO and co-founder of ChromaDex, Inc. Founded in 1999, ChromaDex is now the leading supplier of botanical reference standards and phytochemical products and services to the dietary supplement, nutraceutical, sports nutrition, food, beverage and cosmetic and pharmaceutical markets. With more than 19 years of laboratory, general management, sales, marketing, and business development experience, he provides strategic vision and direction for ChromaDex, Inc. Prior to starting ChromaDex, Mr. Jaksch was with Phenomenex and ICN Pharmaceutical. At Phenomenex, he managed the International Subsidiary and International Business Development divisions. During his tenure there, he established strategic business offices in Australia, England, Germany and New Zealand. Phenomenex is a multi-million dollar international company that supplies over 30 percent of the global market for analytical chemistry supplies. Mr. Jaksch also co-authored a book with Dr. Mark Roman and Dr. Mingfu Wang (Rutgers University) entitled, "The Handbook of Analytical Methods for Dietary Supplements," which was published by the American Pharmacists Association in June of 2005. Mr. Jaksch has a BS in Chemistry and Biology from Valparaiso University.
About Carl Reynolds
Carl Reynolds currently serves as a Senior Advisor in the Division of Dietary Supplement Programs at FDA's Center for Food Safety and Applied Nutrition. He retired from FDA in January 1999 after a career of more than 36 years as an investigator, middle and senior manager. He formerly served as a Regulatory Consultant with AAC/Kendle and EAS Consulting Group where his duties included conducting audits of food, pharmaceutical and nutritional supplement manufacturers. He was an approved auditor under the Natural Products Association's GMP Certification Program for Dietary Supplements and he has testified in Federal Court as an expert witness and provided depositions in food safety and dietary supplement cGMP regulatory issues. He rejoined FDA in his current capacity in October 2009.
About Cynthia Kradjel
Cynthia Kradjel, Business Development Manager for Bruker Optics, a division of Bruker Corporation, has worked with Near Infrared technology for over 25 years. She worked with the US pharmaceutical industry in the late 1980s as they worked to get the technology accepted by regulatory agencies and deployed for routine use; and then with global companies for compliance with multi-compendial guidelines for drum wise testing of incoming raw materials. She has also worked with food and agricultural industries to implement testing methods. Her experience with Natural Products testing led her to the dietary supplement industry in the 1990s. Cynthia has worked with hundreds of dietary supplement companies to outline plans for method development and implementation of FTNIR testing methods and compliance with GMP Guidelines. She has authored hundreds of technical papers, and presented at conferences around the world. She recently authored a Chapter on NIR testing of dietary supplements, published in The Handbook of Near Infrared Analysis, Practical Spectroscopy Series 27, Third Edition, Taylor and Francis. She graduated from Georgetown University with a BS in Chemistry and Polytechnic University with a MS in Chemistry. Cynthia is an adjunct professor at Iona College in New Rochelle, NY.
ChromaDex is a leader in the development of phytochemical and botanical reference standards and the creation of associated intellectual property. ChromaDex is committed to sustainable "green chemistry" and provides the dietary supplement, food, beverage, nutraceutical and cosmetic industries with the novel ingredients, analytical tools and services to meet product regulatory, quality, efficacy and safety standards. Among other things, the Company is currently focusing on clinical studies and the commercialization of its new product, pTeroPure(TM) pterostilbene (www.pteropure.com) as a result of its exclusive worldwide patent rights for pterostilbene. For more information, visit www.chromadex.com or follow ChromaDex on Twitter @ChromaDex.