I would like to introduce you all to member of the McCormick LifeScience Consultants, LLC team, Jacob Cooper, Quality Systems and Regulatory Operations Consultant. Jacob has worked in Quality Systems and Regulatory Operations for nine years, and has experience implementing simple, scaled to purpose quality systems in three different companies.
Take it away Jake!
Imagine you’re tooling back from your holiday extravaganza in Maine in your sleek new drug development car. It’s a tiny little number, fits just you and Aunt Millie. Boy, will you be able to fly in this! But it has these big “REGULATED” stickers all over it. This means that not only do you have to obey the traffic laws (like you were planning to do), you have to be able to prove that you’ve obeyed them at every step of the way.