Dietary Supplement GMP Seminar
Now that the final regulations on good manufacturing practices (GMPs) for dietary supplements are in effective for Dietary Supplement firms with 20-500 employees, EAS Consulting Group is conducting a Dietary Supplement GMP Seminar to train industry on the new rule. Given by former FDA compliance officials, this intensive training program will provide all the information needed to comply with the rule, covering 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 the testing, quality control and distribution of supplements.
DATE AND LOCATION
October 6-7, 2009
EAS Consulting Group - Training Facility
1940 Duke Street, Suite 200
Alexandria, VA 22314
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.
MINIMUM REGISTRATION POLICY
Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by September 22, 2009, and refund the registration fee in full.
CANCELLATION POLICY:
Cancellations received by September 22, 2009 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 notice is given to EAS in advance.
FOR MORE INFORMATION:
Contact Cathryn Sacra at 703-684-4438 or csacra@easconsultinggroup.com
