Friends -

I have a new workshop for drug and device firms that I deliver on site called Dangerous Documents: Avoiding Land Mines in Your FDA Documents and Emails.

The workshop has received an enthusiastic response from employees at Allergan, Chattem, Hill-Rom and Varian. Engineers and software developers have said they wished the workshop had been longer.

I developed the course because of the files -- the hastily written emails and other documents that lie in the files of many companies. Bayer, Merck, Guidant, and Lilly paid large penalties based partly on statements in their files and emails. Had their staff been trained on how to write appropriate documents, these firms might have saved millions of dollars.

In delivering the workshop, I use my background as a former prosecutor and defense lawyer and team-up with the in-house regulatory, quality or compliance professional. Using case studies, we show how documents can be incriminating evidence. The course has attracted some nice press coverage.

If you are interested in learning more about the workshop, please email me at nancy@compliance-alliance.com.

I continue to post documents on the Free Documents page. If you haven’t looked in a while, check them out. 

The results of the 510(k) Survey we did in June, 2008, are attracting lots of attention.

We have continued the discounted price of the audio CDs from the Compliance-Alliance audio conferences. Check out Audio CDs for Sale for specifics.