I got one of those "You have an interview with Coke in the morning" phone calls last night. Coming from ISO with no FDA experience, what should I know going in????

-with trepidation,
Sean

Sean

Working in an FDA environment is similar in many ways to ISO. Yes, FDA systems are a little tighter than ISO systems. The FDA will tell you that not only do you need to maintain quality records but you need to say how long you keep them. They will check to see that you are performing your internal audits, mgmt review, however, they are not allowed to review the contents of the audits or mgmt review meetings. Complaints are another big area for the FDA. All in all the FDA and ISO are very similar. JMHO

Thanks guys. The interview went pretty well, as nearly as I could tell. I should hear from them again (I think). :confused:

Now if I can get a handle on AS and NADCAP before the monday interview.....

:thedeal: