Dietary Supplement GMP Seminar
Now that the U.S. Food and Drug Administration has released its long-awaited final regulation on good manufacturing practices (GMPs) for dietary supplements, EAS is conducting seminars to help industry achieve compliance with the new requirements. This training program, presented by former FDA compliance officials, will provide all the information needed to comply with the rule. It will cover the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with testing, quality control and distribution of supplements.
DATE AND LOCATION
March 17-18, 2009*
EAS Consulting Group - Training Facility
1940 Duke Street, Suite 200
Alexandria, VA 22314
*Held in conjunction with: Ensuring Regulatory Compliance of Dietary Supplement Laboratories, a 2-day seminar held on March 19-20, 2009.
IN-HOUSE SEMINARS
EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost effective alternative to train your employees. It also allows the program to be tailored to your particular needs.
Contact Ed Steele for a price quote. 703-684-4408
INSTRUCTORS
Robert Fish
Robert Fish has been providing independent consulting services since 2003, joining EAS Consulting Group, LLC in November 2006. Prior to that, he worked for AAC Consulting Group, Inc. (AAC) for 9 years and with the Food and Drug Administration (FDA) for 33 years. The last 6 years of FDA service he held the position of Director, Division of Field Investigations (DFI). There he was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections' operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office for 8 years and was also a Supervisory Investigator at the Nashville District Office for 8 years. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to dietary supplements, pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor.
William Ment
William Ment is a contract consultant to EAS Consulting Group. He has 34 years of FDA laboratory experience and has served as a Senior Consultant at Kendle Regulatory Affairs since leaving government service in 1999. Mr. Ment was the Director in FDA’s Baltimore District Laboratory with responsibility for a full range of sample analyses and research studies for imported and domestic products, including pharmaceuticals, dietary supplements, in vitro diagnostic devices, microbiological, environmental contaminants, and extraneous materials/decomposition in foods. He has considerable experience in auditing of QA programs of pharmaceutical and dietary supplement firms and laboratories. His has been active in the training of industry personnel in FDA’s dietary supplement GMP regulations. Mr. Ment is a member of the American Chemical Society.
WHO SHOULD ATTEND?
- Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing, labeling, packaging, storing and distribution of dietary supplements.
- Consultants, auditors, attorneys and others interested in learning about the requirements of the new dietary supplement GMPs and how they should be applied.
AT THE GMP SEMINAR YOU WILL
- Learn the requirements of the final Rule and understand how they differ from the proposed rule that was published in March 2003
- Receive detailed practical guidance on how to apply these requirements.
- Be given an opportunity to demonstrate your understanding of GMPs in group work sessions Be coached on how to prepare for an FDA inspection and how to avoid receiving a List of Objectionable Inspection Observations (Form FDA 483) and the end of an FDA inspection.
SEMINAR AGENDA
Day 1 – (Starts 8:00 am)
- Introduction and Seminar Objectives
- FDA Final Rule: Overview
- Subpart A: General Provisions
- Subpart B: Personnel
- Subpart C: Physical Plant and Grounds
- Subpart E: Specifications
- Subpart E: COAs, Samples
- Subpart G: Requirements for Components,
- Packaging and Labeling
- Subpart D: Equipment and Utensils
- Subpart F: Requirements for Quality Control
- Q & A
- Work Session I (Ends 5:00 pm)
Day 2 – (Starts 8:00 am)
- Subparts H and I: Master Manufacturing Records and Batch Production Records
- Subparts K and L: Requirements for Manufacturing, Packaging and Labeling
- Subpart F: Material Reviews
- Subpart O: Product Complaints
- Subpart J: Requirements for Laboratory Operations
- Documentation and Change Control
- Subparts M and N: Holding, Distribution, Returns
- Analytical Methods and Expiration Dating
- Work Session II
- Regulatory Compliance
- Q & A, Evaluations, Wrap-Up (Ends - 4:30 pm)
SEMINAR HANDOUTS
- Participant’s Manual (with copies of all seminar slides)
- Pocket Guide: 21 CFR Part 111
REGISTRATION INFORMATION
REGISTRATION FEE:
Dietary Supplement GMP Seminar - General Registration $1,200
DISCOUNTS:
Registrants with Promotion codes - Limit one Promotion code per transaction
Group Rate (two or more from same firm) - 10% per person
Federal/State Government Employees - 50% per person
METHOD OF PAYMENT:
Check or credit card payments are accepted.
AREA HOTELS
The seminar is being held within an easy walk of the King Street Metro Stop (a 7 minute ride from Reagan National Airport) in historic Old Town Alexandria, VA. There are many hotels and restaurants to select from. Hotels in the immediate area include:
Westin Alexandria
400 Courthouse Square
Alexandria, VA 22314
703-253-8600
New hotel (opened October 2007) within 1 block of EAS headquarters.
Old Town/King Street Hampton Inn
1616 King Street
Alexandria, VA 22314
703-299-9900
One block from King Street Metro; two blocks from EAS headquarters.
Ask for “EAS Consulting” preferred rate - $189.
Embassy Suites Alexandra – Old Town
1900 Diagonal Road
Alexandria, VA 22314
703-684-5900
Directly across the street from the King Street Metro stop/EAS headquarters.
Hilton Alexandria Old Town
1767 King Street
Alexandria, VA 22314
703-837-0440
Directly across the street from the King Street Metro stop; one block from EAS headquarters.
Residence Inn by Marriott
1456 Duke Street
Alexandria, VA 22314
703-548-5474
Four blocks from the King Street Metro stop; three blocks from EAS headquarters.
Courtyard by Marriott
2700 Eisenhower Ave.
Alexandria, VA 22314
703-329-2323
Two blocks from Eisenhower Metro stop (one stop from EAS headquarters at King Street) or long walk.
Holiday Inn – Eisenhower Metro
2460 Eisenhower Avenue
Alexandria, VA 22314
One block from Eisenhower Metro stop (one stop from EAS headquarters at King Street) or long walk.
CANCELLATION POLICY:
Cancellations received two weeks before each seminar will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as prior notice is given to EAS.
FOR MORE INFORMATION:
Contact Ed Steele at 703-684-4408 esteele@easconsultinggroup.com
