Keynote Presentation

Companies will occasionally have an all-hands meeting, and they want to have a keynote event. Or they have an initiative that requires buy-in from a large group of employees.

It may be a situation where there is a need for better understanding by the staff. Recently, Compliance-Alliance developed a seminar to teach FDA investigators about data integrity — how to look for needs and lapses.

When there is not a specialized need, we present our classic seminar, Dangerous Documents. It applies to any organization, and meets a need that is common to all.┬áSinger’s decades of experience are valuable. The focus is appropriate because the field is one where management is subject to civil and criminal prosecution.


Dangerous Documents

Perhaps not everyone realizes the many dangers their company faces, and how each person can reduce the risk of loss. Things that people write persist in electronic form. Many people write emails. Writers are not always aware that what they write speaks for, and belongs to, the company.

Now in its tenth year, Nancy Singer’s “Dangerous Documents” seminar is as important as ever. High profile people continue their reckless email practices. Healthcare product executives recognize the relevance of training on good documentation, especially since Singer also teaches FDA.

She teaches all of the new FDA reviewers in the Office of Device Evaluation, FDA investigators in eleven district offices, and FDA headquarters staff in five different divisions. Singer is among those teaching FDA investigators what to look for in company documents.

Seminar Demands Involvement

Her success is impressive, but her ambition is not new. Singer has been driven to speak before groups since she joined the primer food & drug law firm after working as a federal prosecutor. She still has a keen perception of any instance where someone is not paying rapt attention while she is speaking. This explains why she will not lecture for longer than seven minutes. Instead, she organizes group activity to reveal the message. This is amazingly successful. Everyone loves her seminars.

Feedback is important. Singer asks everyone to complete a short evaluation. These she reads avidly, looking for anything that anyone did not like or understand. Over 99 percent of the attendees indicate that they found the experience useful, and would recommend it to others. Some even wish that it had been longer, which is amazing for a three or four hour session.

Writing the Compliance Record

Singer continues, “Now that I’ve had the opportunity to visit hundreds of company and government sites, I’m able to go beyond warning people of what not to write. I’m getting better at helping them write what is crucial to record — their compliance story.

“I’ve studied documents written in R&D, quality, engineering and manufacturing organizations in drug and device companies. Many of them are worthless or worse. They lack the facts, miss the details, or contain unsupported statements. Some of those documents are dangerous.”

Dangers in Documents

The most dangerous documents are, of course, the ones that could possibly imply wrongdoing. Also troublesome are documents that conceal compliance by omitting details and supporting evidence that can become essential later. Dangerous documents fail to tell the whole story.

Companies are working to comply with every requirement. The people who write are conscientious, and they mean well. They sometimes don’t know why, how, and what to write.

We can make them better at this part of their job. To make a lasting improvement, we need more than a manual, more than a Webinar. We need an experience of involvement, where employees learn and commit to improving.

See more of the course content and what people have thought about it.