A quick look at the FDA's warning letters site led me to this:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219001.htm
A warning letter to Abbott Diabetes Care, Inc. from 7/2/10
I wanted to share this here because industry have the tendency of hiring QA/Regulatory personnel without the adequate science qualification and hence it effects the quality of the product in the chain.
Anyone can subscribe to updates to the warning letters, they are not a secret. In fact, perusing the warning letters gives one FDA's current thinking, and what they're really scrutinizing in their audits. Very educational!
It's very important for QA/regulatory professional to have adequate Science-Analytical-Method development experience (not a sole law background for RA) and FDA regulatory requirements for Brand and Generic industry. FDA's current thinking may prompt many firms to take action...the foundation of all these laws is the science behind them. I'm happy to see a science-driven FDA...hopefully all this leads to better quality.
Any thoughts or comments?
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219001.htm
A warning letter to Abbott Diabetes Care, Inc. from 7/2/10
I wanted to share this here because industry have the tendency of hiring QA/Regulatory personnel without the adequate science qualification and hence it effects the quality of the product in the chain.
Anyone can subscribe to updates to the warning letters, they are not a secret. In fact, perusing the warning letters gives one FDA's current thinking, and what they're really scrutinizing in their audits. Very educational!

It's very important for QA/regulatory professional to have adequate Science-Analytical-Method development experience (not a sole law background for RA) and FDA regulatory requirements for Brand and Generic industry. FDA's current thinking may prompt many firms to take action...the foundation of all these laws is the science behind them. I'm happy to see a science-driven FDA...hopefully all this leads to better quality.
Any thoughts or comments?

