Dangerous Documents: Avoiding Land Mines in Your Emails and Documents | Jul 28, 2011

“Land mine” is a term we use for something buried in your company that will blow up if it is uncovered. In court, even an innocuous phrase in a private email from one of your employees, such as, “This will negatively impact the bottom line,” could be a land mine. In a products liability action, a plaintiff’s lawyer could use this statement to undermine the credibility of your organization.

When was the last time you cringed after reading an email sent by someone in your organization as you imagined how a prosecutor or plaintiff’s lawyer could use it to imply sinister behavior? Maybe it was just last week or last month. It’s not that your employees don’t care, it’s just that they don’t know.

Dangerous Documents: Avoiding Land Mines in Your Emails and Documents is a 2-hour interactive Webinar where you will discover the potential consequences of writing emails and other documents that are inappropriate. After this Webinar, your employees will be motivated to create correspondence that, if subpoenaed, will demonstrate your firm’s commitment to quality and regulatory compliance… instead of exposing costly and embarrassing surprise.

“This interactive course used good examples and made me more aware of the potential issues that can arise with documentation.”
Senior Regulatory Affairs Specialist

“This course increased my awareness and I will take time to reread my emails before I push the send button.”
Regulatory Trainer and Compliance Specialist

“Dangerous Documents” has been presented at leading corporations such as Medtronic, Siemens, and Allergan. The course has also been delivered as part of the Masters program at the University of Southern California and at several compliance symposia at Harvard University. Participants’ reactions have been overwhelmingly positive. Engineers and software developers have said the course is so valuable that they wished it had continued longer.

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Sections:

  • Senior Management Overview: This section provides a summary of the risks, examples where inappropriate documents have contributed to firms being found liable in products liability actions and the elements of the preventive action program.
  • Middle Management Leadership Education: This section provides activities where managers learn to recognize the risks, reduce their individual exposure to these risks, and guide their direct reports on techniques to ensure that they write complete and accurate documents.
  • Company Wide Education:

* Discuss the do’s and don’ts for handling customer complaints
* Debate whether emails written on company computers should be audited
* Examine warning letters where the government has cited firms for poor documentation
* See how the former NY Attorney General used carelessly written documents
* Analyze a series of statements to determine which are facts and which are opinions
* Rewrite sentences that, when taken out of context, appear to be inflammatory
* Practice substituting less harsh words for inflammatory ones
* Read inappropriate emails from employees of Guidant, Merck, Bayer, Chevron, Arthur Andersen, and Microsoft that were reported in the media

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What You Receive:

  • 3-month subscription to FDA Digest – 483/warning letter e-newsletter
  • Complimentary recording of the event
  • 3-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
  • Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
  • “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)

About the Presenter:

Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for those employed in drug, device and other manufacturing industries. She created the course, “Dangerous Documents” when she was employed as General Counsel for a drug and device firm. While reviewing documents, she noticed that the employees at her firm failed to understand how a plaintiff’s lawyer could use their emails and other documents to the firm’s detriment if the firm was ever sued in a products liability action. She presented the course to her colleagues. The response was uniformly positive. She then took it to other firms, universities and industry meetings.

Singer’s career began as an attorney with the United States Department of Justice where, during a three year period, she successfully prosecuted seven firms for violations of various criminal statutes. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Singer received her B.S. from Cornell University, and J.D. and LL.M. degrees from New York University Law School. During her career she was an instructor at Catholic University Law School, George Washington University Law School, University of Southern California, and at compliance symposia at Harvard University. She received Vice President Gore’s Reinventing Government Hammer Award, the FDA Commissioner’s Special Citation, and the Food and Drug Law Institute’ s Distinguished Service and Leadership Award. Singer is a retired Commander in the United States Naval Reserve.

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Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

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