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, and will be in effect for all Dietary Supplement firms on June 25, 2010, EAS Consulting Group is conducting the Dietary Supplement GMP Seminar to train industry on the new rule. 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.
DATES AND LOCATIONS
April 27-28, 2010
EAS Consulting Group Headquarters
1940 Duke Street
Suite 200
Alexandria, VA 22314
703-684-4438
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
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.
Dean Cirotta
Dean Cirotta recently joined EAS Consulting Group as part of the group's expansion of services to the pharmaceuticals sector. Mr. Cirotta has 20 years of experience in a range of pharmaceuticals firms, including senior management roles with responsibility for regulatory affairs, compliance and quality assurance.
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 April 13, 2010, and refund the registration fee in full.
CANCELLATION POLICY:
Cancellations received by April 13, 2010 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
