1. We studied that 10 years ago, why are you doing it again?
2. Where did Joe retire to? Can we find him?
3. Where can we find that study?
4. I know it is in the database, but I haven’t been able to bring it up.
5. Why does our filing not match our master batch record?
6. Where can we find the information to answer the FDA inspector’s question?
7. Can we send out an email asking to see if anyone knows about this?
The above questions are courtesy of John McShane, head of Global Quality System Biologics for Roche/Genentech.
"We have a responsibility to get the best and most effective drugs to market and to patients who need them," he says. "We can’t meet this responsibility without effective knowledge management."
McShane spoke this week at Pharma Conference’s GMP by the Sea 2011. in Tampa. Here below is a brief summary of McShane's Current Thinking: