What is a significant trend in your area of expertise that will have a major impact in the next 1-2 years?

Mark Dockter

President / CGMP Consultant/MD Pharma Consulting, LLC - AdvisoryCloudTM

FDA-regulated industries can expect more stringent government enforcement based on the risks of their products to end-users.  Since a company's ability to maintain regulatory compliance is directly reflected in the robustness of their quality systems, businesses should expect to invest significanty in their quality systems.  Just as important is a comittment to create and sustain a quality culture that permeates every department within their companies.