Next Upcoming Webinar: What is a Scientifically Valid Method Part 3 of a 5 Part Webinar Series – October 30, 2017

Specializing in FDA Regulatory Matters

How to Select and Qualify a Contract Laboratory

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar will take place at 1:00 pm Eastern, with dates as follows:

  1. October 6th – 21 CFR 111 GMP Laboratory Overview [Register]
  2. October 19th – Using Analytical Instrumentation Appropriately [Register]
  3. October 30th – What is a Scientifically Valid Method? [Register]
  4. November 9th – Developing Compliant Specification – No “By Inputs” Here [Register]
  5. November 20th – How to Select and Qualify a Contract Laboratory [Register]

Instructor:

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin 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 training via seminar, webinar, and on-site presentations.