Former FDA Prosecutor & Regulatory Educator
Nancy SingerJ.D., LL.M.
Created Dangerous Documents — Avoiding Land Mines in Your FDA Records and Emails, presented at 75 drug and device companies and the FDA staff college.
- Documentation
- Training
- Legal
- Records
20+ years training FDA and industry officials
Background
Nancy Singer is a former FDA prosecutor, defense lawyer and trade association executive with more than 20 years of experience training FDA and industry officials.
She created the course Dangerous Documents — Avoiding Land Mines in Your FDA Records and Emails, which shows how prosecutors, plaintiff lawyers and the media can infer inappropriate conduct from short, cryptic or sarcastic emails. She has presented the course at 75 drug and device companies, the FDA staff college, public seminars and universities.
She received Vice President Gore's Reinventing Government Award and the FDA Commissioner's Special Citation, and was selected as one of the 100 most notable people in the medical device industry.
What Nancy does on an engagement
- Documentation practice and records training
- Dangerous Documents course delivery
- Regulatory training program design for FDA and industry staff
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