by Tony Chen
FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.
Now, in our unique 90-minute webinar, you can learn the detailed trends of 483 and warning letter for 2012. Our speaker, Dennis Moore, Managing Partner, AUK Technical Services, is a 28 year veteran FDA investigator. Dennis recently had unlimited and highly unusual access to FDA 483 and warning letter trend data from 2010 and 2011. He has assembled a presentation that reveals a level of detail of FDA trend data that you cannot find anywhere else.
We have never seen this amount of detail in any FDA data on 483s and warning letters – ever. We also have never seen so much detail on data this fresh. Anyone who deals with FDA data regularly knows that most of their released data is 4 years old. This data is only a year old!
A few things that you will learn in this 90 minute, detail-packed webinar:
- Top warning letter trends for 2012, such as more 806 enforcement
- The Top 10 QS 483 Observations for 2010 and 2011
- Most common quality system failures for drugs for 2010
- Top drug and device citations in 483s for 2010
- Top drug and device warning letter citations for 2010
- Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
- Details on clinical investigator, sponsor/monitor and IRB audits for 2010
- Most common sponsor deficiencies for 2010
- The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
- The total number of 483s issued in 2010 and 2011 – an all time high
- Total CAPA 483 observations in 2010
- How long to receive a warning letter, based upon which offices issues it
- 483 inspection targets for drugs and devices for 2010, 2011, and 2012
- Total warning letters issued by drug and device category in 2010
- Which district offices write the most warning letters
- How long to receive a warning letter, based upon issuing office
- Warning letters issued by QS system for 2010
- 483s broken down by QS subsystem for 2010
- Warning letters by CFR section
- Top device 483 observations for 2010
- Details on process validation observations for 2010
- Design control 483 observations by category for 2010
It is very unusual to see this amount of detail in FDA data, especially data that is this recent. We have never seen it covered anywhere else. You will learn detailed, insider information on how FDA is thinking on 483s and warning letters. You can learn all kinds of details that can be a huge help to your firm when the next inspection rolls around.