February 22, 2018; 1:00 – 3:30 PM Eastern and,
March 1, 2018; 1:00 – 3:30 PM Eastern
Based on 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
A Two-Part EAS Online Exclusive
The GMPs dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to comply with even the basic tenants of the regulation. In light of this, EAS Consulting Group, leaders in regulatory consulting services and educational seminars, will host an online exclusive GMP Compliance Short Course. The two-part course will cover the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs). It will also address the top 5 observations cited in FDA Warning Letters since 2010 which are Specifications, Master Manufacturing and Batch Production Records, Quality Unit (collectively Quality Assurance and Quality Control) Responsibilities, Product Complaints, and Holding and Distribution Operations.
Participation will provide a thorough initial training for personnel unfamiliar with GMPs, and can serve as a refresher and annual GMP training requirement for previously trained personnel.
Session 1 – February 22, 2018
- FDA Enforcement
- Physical Plant and Equipment Sanitation
- Standard Operating Procedures (SOPs) and Document Control
- Good Documentation Practices
- Quality Unit Responsibilities
- Product Complaints
Session 2 – March 1, 2018
- Master Manufacturing and Batch Production Records
- Holding and Distribution
- Own Label Distributor (OLD)
Registration fees are per person. Each participant will receive a completion certificate at the conclusion of the online Short Course. A 10% discount is offered to companies with two or more participant registrations.
EAS Clients: free
(use coupon code CLIENTWEBINAR)
Non-EAS Clients: $99
Tara Lin Couch, Ph.D.,
Senior Director, Dietary Supplement and Tobacco Services
Dr. Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory trainings via seminar, webinar, and on-site presentations.
Independent Advisor, Quality and Compliance
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.
Of Counsel, Rivkin Radler, Attorneys at Law
Attorney Marc Ullman represents clients in matters relating to all aspects of the firm’s practice, including Food and Drug Administration and Drug Enforcement Administration matters, regulatory issues, Federal Trade Commission proceedings and litigation. He practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.