Oct 2, 2015 | Drugs, On Demand Webinar
With FDA inspections becoming more frequent, particularly in the dietary supplement world, it is imperative that companies familiarize themselves with how to host and manage such an inspection. We say “manage an FDA inspection” because the more knowledge a company has the better able it will be to make the inspection process move smoothly in the direction that you help set. To provide you with that knowledge, this webinar will cover:
Oct 1, 2015 | Drugs, Issue of the Month
By EAS Senior Consultant Robert C. Fish An FDA drug inspection can be a very stressful experience. If it is a pre-approval inspection there is a lot at stake concerning the outcome. If the company does not pass, the application (NDA/ANDA) may not be approved or the...
Oct 1, 2015 | Foods, FSMA Perspective
The Food and Drug Administration released two key FSMA-mandated regulations last month — a final rule on current good manufacturing practices (CGMPs) and risk-based preventive controls for food for humans and a related final rule on food for animals. The rules...