Conference Abstract

From product submissions to the FDA-CTP inspection process, industry is faced with significant compliance decisions, milestones and business risks. Since 2009, regulated categories accumulated knowledge, resources and agency experience. 2018 brings “Deemed” categories into the mix. This one-day Workshop provides an all-industry forum for colleagues working on the ground to share experiences, tips and the intricacies of their compliance experience from the product submission to the inspection process. Inspired by EAS Consulting and feedback from the TMA 102nd Annual Meeting, TMA is convening this workshop to provide industry with a nuts-and-bolts understanding of product submissions and their interrelation to the inspection processes from peers and experts doing this work themselves. Come to share and learn tips and information on submissions, inspection preparation and leave in a better position to evaluate where you stand.

The morning will consist of Working Groups divided by submission type: Grandfather, Substantial Equivalence and PMTA. Hear from colleagues in industries that navigated submission requirements, those in “Deemed” categories gearing up and experts providing key services and legal advice. You will leave with a better understanding of the requirements and product implications of each submission pathway.

Following lunch, the Workshop comes together; building upon the product submission Working Groups, the focus shifts to FDA inspections. Consultants and industry experts take us through everything associated with an inspection – it’s a lot more than you might think. Learn where the submission fits in, what you need to do to prepare and what to expect before, during and after from the people that have been through the process, experienced it and consult with industry now. 


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