Message from Nancy Singer

Friends -

A few years ago when I was the general counsel for a drug and device company, I saw that the employees had no idea how a plaintiff’s lawyer or a prosecutor could use their emails and other documents to wreck the company if it was ever sued in a product liability action. I created a seminar to raise their awareness and change their behavior.

Everything written by every employee today stays around and is retrievable forever. This is a radical change from the ’90s and before. Employees now have more power. It is their writing that stays around. They must be careful, but this is not what I saw. At my company, people were writing short, cryptic, sometimes sarcastic emails that a lawyer could use to imply misconduct. They were also writing personal emails on the company computers.

I left my general counsel position so I could help other companies. I developed my seminar concentrating on email and other FDA documents that employees write routinely. I have found that it does no good to tell people about the problem. They’ll nod — and forget. Lecturing is a waste of time. To change behavior, they must be involved. I form them into cross functional teams of three to five, and give them problems to discuss. Using case studies, we see how documents can become incriminating evidence. I use my background as a federal prosecutor and defense lawyer for persuasion, and I team-up with an in-house regulatory, quality, or compliance professional to be the authority for the company.

I’ve presented the seminar at more than 75 companies, to FDA ODE and compliance officials at CDRH Staff College, to supervisors who oversee FDA investigations at FDA’s ORA University, and to over 450 investigators in FDA district offices. According to the evaluations (which I read avidly), I see that I can actually change people’s behavior. I love it when an R&D person, after working through a four hour session, writes, “I now see the light. I wish the training were longer and everyone in the department could attend.” I call the seminar, “Dangerous Documents: Avoiding Land Mines in Your FDA Documents and Emails.” As the title indicates, I can incorporate material for FDA submissions, CAPA documents, and complaint records. 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. To receive periodic emails for my upcoming events, and to take part in surveys, please get on Nancy’s List.” I also produce and present audio conferences for FOI Services on quality and regulatory issues.

Take care,

Nancy