Premium Series—Dietary Supplement GMPs: What Can Industry Do Better?

INSIDER Premium Series

Co-sponsored by:

Date/Time: Available On-Demand until December 31, 2012

CRN Member Price:
$149*
*Discount subject to verification. Registrants that use the CRN member discount and are not members will be charged the additional $50 towards full registration.

Non-CRN Member Price:
$199

Objectives: This Webinar will examine key elements of GMPs for dietary supplements and what industry can do to improve its record of successful inspections. The first four years of GMP inspections have been a steep learning curve for industry and FDA. Inspection reports and warning letters reveal several patterns of deficiencies identified during inspection. Raising awareness about deficiencies and identifying ways to address them is the next step in achieving an industry-wide high level of compliance with dietary supplement GMPs. This Webinar will host FDA and industry experts on several key GMP requirements where inspections have demonstrated patterns of deficiency, such as the requirements to establish specifications for raw ingredients, test incoming ingredients, verify contents of finished products, follow master manufacturing, as well as other often overlooked GMP provisions such as the “Umbrella” clauses that are requirements that apply to all the points on the supply chain, including manufacturers, suppliers, transporters, or distributors.

Speakers:

Douglas "Duffy" MacKay, N.D., Council for Responsible Nutrition

Douglas “Duffy” MacKay, N.D., is Vice President, Scientific & Regulatory Affairs for the Council for Responsible Nutrition (CRN). Dr. MacKay is a licensed Naturopathic Doctor and was a co-owner and practitioner in a family-owned New Hampshire complementary and alternative medicine private practice for seven years. In addition to his hands-on experience as a practitioner in the field of integrative medicine, he spent eight years working as a medical consultant for two companies in the dietary supplement industry, including four years as an executive with Nordic Naturals, in charge of clinical research. He previously served as Technical Advisor for Thorne Research. Dr. MacKay has published articles in peer-reviewed journals, and serves on the Editorial Board of two peer-reviewed publications: the clinical journal Alternative Medicine Review and the official publication of the American Association of Naturopathic Physicians, Natural Medicine Journal. Dr. MacKay earned his B.S. in Marine Sciences from the University of California, Santa Cruz and his N.D. from the National College of Naturopathic Medicine in Portland, Oregon. Dr. MacKay is licensed in the state of New Hampshire

Joy Joseph; president and founder, Joys Quality Management Systems
Topic: Master manufacturing records and supplier qualification

Joy A. Joseph, president and founder, Joys Quality Management Systems is the former vice president of quality, technical operations, scientific affairs and R&D for Pharmavite LLC. Joseph has more than 40 years of experience in quality control systems, regulatory affairs, product development and scientific affairs both in the pharmaceutical and dietary supplement industries. She has been the chairman of the USP Committee of Revision for Nutritional Supplements Non-Botanical; is course director for the Center for Professional Advancement; is a member of the Council for Responsible Nutrition's (CRN) regulatory affairs committee; and serves on several of the scientific advisory boards including the University of California, School of Pharmacy. In January 2005, Joseph authored a chapter on “Regulation and Quality Issues Worldwide” for Regulation of Functional Foods and Nutraceuticals: A Global Perspective. In 2005, Joseph was the recipient of CRN's annual “Steuben Apple Award” for outstanding contributions to the industry.


Nicki Jacobs; president, Jacobs Compliance Services
Topic: The “Umbrella" aspects of GMPs that are the common requirements for companies whether they are manufacturers, suppliers, transporters, warehousers, brand holders, or distributors.

Nicki Jacobs has been involved in the pharmaceutical, dietary supplement, and food processing industries for more than 30 years. During those years, Jacobs has had hands-on experience making tablets, capsules, softgels, powders, and liquids. Within the Dietary Supplement Industry, in addition to having been directly involved with Personnel, Customer Service, Formulation, Purchasing, and Materials Management, she has held executive management positions in Accounting, Technical Service, Regulatory Affairs and Quality. Jacobs has been active in regulatory affairs since air quality issues in the 1980's forced the transition from use of quick-drying organic solvents to aqueous systems. More recently, she has been a consultant to industry, specializing in GMPs and the other regulations that form the operating environment for Dietary Supplement manufacturers and their suppliers. Jacobs is currently a member of the American Society for Quality (ASQ), the Orange County Regulatory Affairs Discussion Group (OCRA) and the Nutrition Industry Association (NIA). Nicki Jacobs completed the Better Process Control School program at Chapman University in 2008 and became an ASQ Certified HACCP Auditor in 2011. Jacobs Compliance Services is a proud member of the Council for Responsible Nutrition (CRN.)

Daniel Fabricant, Ph.D.,
Director, Division of Dietary Supplement Programs (DDSP), CFSAN, FDA

Daniel Fabricant was named Division Director for Dietary Supplement Programs at the Food and Drug Administration (FDA) in February 2011. Dr. Fabricant directs and coordinates policy, budget, personnel, regulatory priorities and administrative activities within the division. He advises on policy, and management issues and decisions, and provides expert advice and assistance to the Office of Nutrition, Labeling, and Dietary Supplements Director, CFSAN management and other key FDA officials on dietary supplement programs, new dietary ingredient safety assessments, good manufacturing practices, adverse event monitoring and related activities pertaining to dietary supplements. Dr. Fabricant is responsible for the full implementation of DSHEA through the interpretation and enforcement of dietary supplement requirements that ensure the safety and truthful labeling of dietary supplements, support legislative compliance, enforcement and public affairs initiatives.

Brad Williams, GMP Team Leader, DDSP, CFSAN, FDA

Mr. Williams is currently a manager in the Division of Dietary Supplement Programs, Office of Nutriton, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, where he is instrumental in implementing the Dietary Supplement Current Good Manufacturing Practices regulations. In addition, he has been involved in developing the Center’s Dietary Supplement Regulatory Strategic Plan, heading the Enforcement/Safety Strategy Team, which developed regulatory policies and procedures for enforcement of the Dietary Supplement Health and Education Act. Mr. Williams has also served as Director - Division of Nonprescription Drug Compliance, Chief – Generic Drug Compliance Branch, Supervisory Chemist for New York Regional Laboratory, and radiochemist at FDA’s Winchester Engineering and Analytical Center, following service as a neurochemist with the Veteran’s Administration Research Service. Mr. Williams is a 1971 Chemistry graduate of Curry College, Milton Massachusetts and studied graduate level Chemistry at Boston College and Providence College.

Angela Pope, Consumer Safety Officer, GMP Team, DDSP, CFSAN, FDA

Angela Pope is serving as a Consumer Safety Officer in the Office of Nutritional Labeling and Dietary Supplements in the Division of Dietary Supplement Programs, Enforcement and Implementation Team at the Center for Food Safety and Applied Nutrition. Presently, Ms. Pope is working directly with the enforcement and implementation of the Current Good Manufacturing Practices for Dietary Supplements. Angela has also served in other positions at CFSAN which included the Small Business Notification System and Food Labeling. Prior to coming to FDA Angela worked with the Center for Substance Abuse Treatment and the United States Senate Committee on Labor and Human Resources on Capitol Hill. Angela received her Master’s in Management/Marketing and a Bachelor of Science degree from the University of Maryland/University College in College Park, Maryland.

Carl Reynolds, Senior Consultant to DDSP, FDA

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.

**All registration fees are non-refundable. The Webinar will be available on-demand through December 31, 2012