Preparing for an FDA CTP PMTA Pre-Approval Inspection

In Section 902 and 906(e)(1) of the TCA, a tobacco product is considered adulterated if the methods used in, or the facilities or controls used for, its manufacture, packing, or storage do not meet Current Good Manufacturing Practices (cGMPs). Although the FDA has not yet issued these for tobacco and deeming products, the FDA is “hard at work” on the Tobacco Product Manufacturing Practices (TPMPs), that will be the cGMPs for tobacco. An inspection of the manufacturing facilities as well as clinical and non-clinical laboratories to assess compliance with cGMPs, and the forthcoming TPMPs, will be a critical part of the FDA’s substantive review of all submitted PMTAs.

Join EAS Consulting Group’s Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and EAS Independent Consultant, Charlotte Peyton, for a comprehensive look at preparing for FDA’s PMTA pre-approval inspections. Learn what to expect based on EAS’s direct participation in some of FDA’s initial inspections and how to ensure your facility and staff are prepared to successfully manage your FDA inspection.

About the Presenters

Tara Lin Couch, Ph.D., EAS Consulting Group

Dr. Tara Lin Couch, Senior Director of Dietary Supplement and Tobacco Services, 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 pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous 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.

Charlotte Peyton

EAS Independent Consultant, Charlotte Peyton, has extensive experience with FDA Current Good Manufacturing Practices (cGMPs) in pharmaceuticals and dietary supplements, as well as EPA Good Laboratory Practices; and has been in a Quality Control environment for 35 years. She excels at the design and implementation of quality systems, especially those in the laboratory, that are practical and efficient, but also fully compliant with cGMPs. She is an expert at analytical test method development and validation. Ms. Peyton also has significant experience, both internally and as a consultant, in supporting product development, formulations, and manufacturing. In addition, Ms. Peyton has management experience in both Quality Control and Scientific Affairs.