Tag Archives: regulatory

Top 31 Websites (and Tweeters) on the FDA

If any part of your life includes trying to figure out how to work smarter with the FDA, this is for you.  Here’s our list of the top 40 31 online destinations on the FDA and some of the key industries it regulates.   We applied only one criteria to make it on this list:  free, up-to-date, and valuable content. Continue reading

So…you’re the new QA person?

New heads of Quality Assurance come into pharmaceutical companies all the time for various reasons. If you are the new head honcho of quality, hopefully you were able to get some sense for the reasons for the vacancy during the interview process. I recognize that this is not always easy in an interview situation.

I have heard such explanations as: we’re looking for someone with more of a business perspective; we’re looking for a fresh approach;  we’re looking for a partnership with QA; we’re looking for an operations-oriented QA; or we’re looking for a more progressive QA.

Actually, these all sound very positive and a highly desirable situation for a new, enlightened head of QA looking for a challenge. But like the Rorschach test, these explanations could always be interpreted various ways, some of which would be troublesome for the newbie who understands the regulatory role of QA. Continue reading