Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society




Dangerous Documents: Avoiding Land Mines in Your

FDA Records and Emails


What to Say in the C Suite – and How to Say It

October 17, 2019

Springhill Suites, Denver, CO 



“Nancy’s Dangerous Documents course addresses issues that no one else talks about. In a high- energy session where all attendees participate, she structures activities to help people discover how the legal system really works. Denise Dion, VP QA/RA EduQuest, former FDA Investigator


“Nancy’s class, What to Say in the C Suite - and How to Say It, is fantastic! I learned many useful techniques that I continue to use. I would recommend it to any professional who wants to stand out." Daniela Drago, Associate Director Regulatory Affairs, Bausch and Lomb


Her Background:

  • Former FDA prosecutor and defense lawyer
  • Senior Vice President, AdvaMed’s Medical Technology Learning Institute
  • Executive Director, Food and Drug Law Institute (FDLI)


Where She Has Presented These Courses:

  • FDA – To all new reviewers at CDRH and to investigators in FDA district offices
  • Academia George Washington University, Harvard University, Johns Hopkins University
  • Medical device, drug, and biotech companies – more than 150 companies


Dangerous Documents: Avoiding Land Mines in

Your FDA Records and Emails

To survive in our litigious society, organizations need to have the right communications culture. Everyone must understand what they should, or should not, write in their emails and other documents. Attendees will learn the potential consequences of writing emails and other documents that are inappropriate. Participants will create correspondence that, if subpoenaed, will demonstrate their firm’s commitment to quality and regulatory compliance… instead of exposing costly and embarrassing surprises.

Topics include:

  • Who should not be writing opinions on regulatory issues
  • The unrecognized dangers in casual emails
  • Words that will attract the attention of prosecutors or plaintiffs’ lawyers

What to Say in the C Suite – and How to Say It

When an employee requests a meeting with top management, the executive expects the employee to explain the issue succinctly. The session will demonstrate how to prepare and describe an issue using the “What”, “So what”, “Now what” pattern. Attendees will also learn how to respond to an executive’s probing questions.  They will be divided into teams, provided case studies, and be given the opportunity to apply the concepts.

Topics include:

  • The traits that enhance or impair credibility
  •  A technique to explain a complicated issue without rambling
  • Tips for anticipating and responding to difficult questions



Thursday, October 17, 2019



One day program fee includes continental

breakfast, lunch, and materials                             $300.00


To register to go



Springhill Suites by Marriott/Denver Downtown

1190 Auraria Parkway

Denver, CO 80204



If you have any questions or need additional information, contact Nan Matthews,


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Rocky Mountain Regulatory Affairs Society


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