Writing under Pressure

Nancy Singer founded Compliance-Alliance in 2004 to help professionals employed in the drug and medical device industries to establish a culture of compliance. Now she has added three new seminars to the popular Dangerous Documents. These seminars improve writing, speaking, and participation in meetings.

The topics come from Singer’s own needs. She had established her speaking role, but writing was difficult. She studied and researched, and created a seminar that gives people the skill and confidence to write a memo quickly and easily that is clear and relevant.

The Experience

Singer’s seminars are very well received. She asks everyone to complete a short evaluation. She reads them avidly, looking fanatically 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 hour session.

Writing the Compliance Record

Having visited more than 100 company or government sites, Singer is able to go beyond warning people of what not to write. She is now helping them write what is crucial to record — their compliance story.

Singer has studied hundreds of 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 the documents are dangerous.

The 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 change their behavior, we need more than a manual, more than a Webinar. We need an experience. With involvement, employees learn and commit to improving.

Targeting medical product companies follows from Singer’s decades of experience. The focus is appropriate because the field is one where management is subject to civil and criminal prosecution.