UNPA Seminar: Dietary Supplement GMP Training Course


8:00 am
Introduction / Course Logistics & Objectives

8:30 am

I. Historical Perspective
Background and Overview of Dietary Supplement GMP Regulations
Regulatory Authorities for Dietary Supplements: Pre-GMP

10:00 am

10:15 am

II. Who • What • Where • When • Why
• Subpart A – General Provisions / Definitions Exercise
• Subpart B – Personnel
• Subpart C – Physical Plant and Grounds
• Subpart D – Equipment and Utensils

12:00 pm

1:00 pm

Review of Part II – Exercise
III. Production and Process Controls
• Subpart E – Production and Process Control System
• Subpart F – Quality Control
• Subpart G – Components, Packaging and Labeling

3:15 pm

3:30 pm
• Botanical Authentication and Quality Assessment
• Method Development of the Analysis of Dietary Supplement Products
• Analysis of Adulterants in Dietary Supplements

4:45 pm

5:00 pm


8:00 am
• Subpart H – Master Manufacturing Record
• Subpart I – Batch Production Record
• Subpart J – Laboratory Operations
• Subpart K – Manufacturing Operations
• Subpart L – Packaging and Labeling Operations

10:00 am

10:30 am

Quality Control Exercise
Review of Part III – Exercise

12:00 pm

1:00 pm

IV. Product Handling and Recordkeeping
• Subpart M – Holding and Distribution
• Subpart N – Returned Dietary Supplements
• Subpart O – Product Complaints
• Subpart P – Recordkeeping

3:00 pm

3:15 pm
Case Study Exercises

4:30 pm
Questions & Answers
Review & Discussion

5:00 pm

Click here
to download the registration form.


Allen D. Gelfius
Consumer Safety/Training Officer
U.S. Food & Drug Administration
Division of Human Resource Development (DHRD)
11919 Rockville Pike, HFC – 60
Rockville, MD 20852
Phone: (301) 796-4517
Fax: (301) 827-8708
Email: [email protected]

Allen Gelfius is a trainer for the FDA Division of Human Resource Development. He develops training courses and educational materials, primarily for state and local regulators, on food safety issues ranging from HACCP principles and the National Voluntary Program Standards to the Food Code, Dietary Supplement Good Manufacturing Practice Regulations, and other regulatory and industry initiatives designed to reduce the risk of foodborne illness. He also coordinates the delivery of these training courses in various states across the country and participates in the instruction and presentation of the course materials.

Prior to joining FDA, Allen completed his B.S. degree in Public Health at Indiana University and then worked for 12 years in the Hawaii State Department of Health’s Food and Drug Branch as a field inspector (for the first 4 years) and then as the Data & Training Manager. His work included management of inspection data; the promulgation of laws and regulations to regulate foods, drugs, cosmetics, and medical devices sold in Hawaii; and the development and implementation of training programs and educational materials on various public health issues. Allen was awarded the 1995 National Achievement Award from the Association of Food & Drug Officials (AFDO) for his efforts in providing training and education to regulators, industry representatives, and the general public on food safety and other public health issues. His training efforts have covered issues such as seafood HACCP principles; food microbiology and foodborne illness investigation; nutrition labeling; dietary supplement safety, leaching lead in ceramics; and safe foodhandling practices, for which he led the Hawaii Food Safety Advisory Council in the development of a training video and education program targeted at newly-hired foodhandlers in retail food and food service operations. Allen has been an active member and served on various boards and committees of the Association of Food and Drug Officials, the Conference for Food Protection, and the Institute of Food Technologists.

Dr. Ikhlas Khan is the Director of the FDA Center of Excellence, Research Professor, as well as Professor in the Department of Pharmacognosy at the National Center for Natural Products Research at the University of Mississippi. Additionally, he is the Director for Sino-US TCM Research Center; Director, Center for Research of Indian Systems of Medicine (CRISM); Research Professor and Coordinator for Natural Products Research, Center for Water and Wetlands Research; and Adjunct Professor, Chinese University of Hong Kong. He received a B.S. in Chemistry in 1980 and a M.S. in Organic Chemistry in 1982 from the Aligarh Muslim University in Aligarh, India. Dr. Khan then received a Ph.D. in Pharmacy from the Institute fuer Pharmaceutische Biology in Munich, West Germany in 1987 and postdoctoral studies at Swiss Federal Institute of Technology (ETH) Zurich. After completing his education, Dr. Khan began his career with the University of Mississippi in 1992 as a research scientist. He became a research assistant professor in 1995, and was promoted to research associate professor and director of the FDA program in 2001, assistant director of the center in Oct. 2002 and to professor in July 2005.

Dr. Khan’s primary research interests include analytical fingerprinting for standardization of herbal products, and bio-analytical approaches to improvement of product quality and safety.
Dr. Khan has authored or co-authored over 300 original research articles, publications, or reviews. He has been an invited speaker at numerous events. Dr. Khan serves as reviewer for several journals, including Co-editor of Planta Medica and foreign editor for J. Traditional Chinese Medicine.

Dr. Khan is the recipient of numerous awards, including: most recently Food and Drug Administration’s Commisioner’s Special Citation, June, 2009; the Norman R. Farnsworth Excellence in Botanical Research Award (2009); the Cumberland Pharmaceuticals Inc Faculty Research Award, 2007-2008, School of Pharmacy; ISHS Award for Meritorious
Service, 2005; Researcher of the Year in the National Center for Natural Products Research, 2001; Faculty Research Award, School of Pharmacy, 2001-2002.

Dr. Khan serves on several committees of National Center for Complementary and Alternative Medicines, Washington, DC. which include serving as Invited Reviewer and as a Committee Member of the Product Quality Working Group. Additional appointments to national and/or international committees include membership of expert panel of United States of Pharmacopoeia (USP) Committee; Advisory Board of the American Botanical Council; Expert Advisory Committee, Natural Health Directorate, Health Canada.

Memberships to scientific organizations include fellowship of the American Institute of Chemists; member of the American Chemical Society; the Society of Medicinal Plant Research; The American Association for the Advancement of Sciences, and the New York Academy of Sciences. He is a member of the American Society of Pharmacognosy, where he served as Chair of the Constitution of By-laws Committee in 1998. He also served as a WHO consultant in Vietnam in 2002. Honorary memberships of Sigma Xi, the Scientific Research Society, and Rho Chi, the Pharmaceutical Honor Society.

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