Dietary Supplement GMP Refresher Training
November 12, 2019
Plainview, NY
The Good Manufacturing Practices (GMP) dictated in FDA’s 21 CFR 111 require that "Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions". In order to maintain compliance with this requirement, most companies require that employees attend an annual GMP refresher training. Training programs ensure a deeper understanding of how to perform specific job responsibilities in a GMP compliant manner.
EAS Consulting Group, leaders in FDA regulatory is pleased to offer a new one-day refresher training to help firms meet their training requirements in an in-person personalized setting, providing an opportunity to learn directly from our GMP experts and ask specific questions regarding their GMP issues or situations.
Dates and Location
November 12, 2019
Plainview, NY (Long Island area)
Hilton Garden Inn Melville
1575 Round Swamp Road
Plainview, New York 11803
Registration
$300
Discounts
Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)
Registrants with Promotion codes - Limit one Promotion code per transaction
Includes:
- Participant’s Manual with presentation slides
- Pocket Guide: 21 CFR Part 111
- Lunch
Instructor
Heather Fairman, Independent Consultant
Who Should Attend?
- Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
- Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.
Minimum Registration Policy
- Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.
Cancellation Policy
- Cancellations received before 46 days prior to the training event 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 Amy Scanlin at (571) 447-5508 or ascanlin@easconsultinggroup.com
Mr. Fish joined EAS Consulting Group, LLC in November 2006 after ten years consulting for FDA regulated industries. He spent 33 years with Food and Drug Administration (FDA), the last 6 years of that service as Director, Division of Field Investigations (DFI). 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 and was also a Supervisory Investigator at the Nashville District Office. 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 pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.
Tim Stewart is a Ph.D. chemist who advises clients on FTC, AG and FDA regulatory compliance issues such as Customs and Border Patrol, Import Alerts, State and Federal observations/violations, Consent Decrees, California Proposition 65 requirements, and vendor qualifications. Prior to consulting, he worked at Paragon Laboratories as a Quality Control Manager and researcher at both Harvard Medical School and the University of Southern California.