Dangerous Documents

 

Avoiding Land Mines in Your Emails and Documents

The Problem

“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.

Testimonials

 

 

MEDTRONIC

“I learned techniques to address issues in a positive way, so they do not become bigger issues.”
Gail Block, Project Manager

“I now will be more careful about how I will state things in my emails.”
Sally Quest, Buy Planner

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 was 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. “This interactive course used good examples and made me more aware of the potential issues that can arise with documentation.”
Catherine Perrone, Senior Regulatory Affairs Specialist
Every day thousands of emails are sent by your server, which because of technology, can be retrieved indefinitely. As we say, “Documents are like diamonds – they are very precious and they last forever.” “I will write fewer emails and use more direct communication.”
Al Beatrez, Commercial Release Manager
To survive in our litigious society, organizations need to have the right communications culture. Everyone needs to understand what they should, or should not, write in their emails and other documents. “I will not leave blanks in forms.”
Stephanie Elhard, Senior Safety Manager
Industry leaders like Pfizer, Bayer, Guidant and Eli Lilly have learned the hard way when they were involved in costly lawsuits. Recently the media have reported that Wyeth’s reserve for Fen-Phen litigation is $21 billion and Merck’s exposure to Vioxx lawsuits may total as much as $50 billion. During discovery, these companies were forced to produce documents that contained embarrassing, inflammatory statements which contributed to their expensive settlements. In a particularly noteworthy case, Microsoft was subject to the same fate after it came to light that Bill Gates wrote in an email, “How much do we have to pay you to screw Netscape?” “I will rethink sending personal emails.”
Teresa Peterson, Buyer Planner

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

All of your employees must know how to write emails and other documents that are complete and accurate and do not create land mines. “I will look at what I write from an outsider’s perspective who is trying to tell a story.”
Jenn Dolan, Technical Sourcing Specialist
The Solution

Compliance-Alliance is the industry leader in offering a complete package designed to train your employees and reduce your risk. “Dangerous Documents: Avoiding Land Mines in Your Emails and FDA Documents” is an interactive educational program. By participating in the program, your employees will discover the potential consequences of writing emails and other documents that are inappropriate. They 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 surprises.

SIEMENS

“I will pay more attention to non-project related documents.”
Jim Wade, Systems Engineer

“I enjoyed the stimulating pace and clear material.”
Alice Forinas deleon, Quality Assurance

“I will use more precise and objective words.”
Aiying Sun, Manager Quality System Validation

“Dangerous Documents” has been presented at leading corporations such as Medtronic, Siemens, Intel, 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 than three hours. “I appreciated the exercises and the instructor’s ability to make people participate.”
Jorge Bohorquez, Applications Specialist“I enjoyed the interaction as this provided a different way of looking at the same situation.”
Ramin Nekouka, Senior Manger Technical Services
There are four components in the program:

1. Senior Management Overview

This session 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.

(1-hour session)

“I will be more mindful of my word selections in emails, text messages and other documentation.”
Myrtis Randolph, Clinical Application Tester
2. 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.

(2-hour session)

ALLERGAN

“The course was very different than other training we have had. It was very informative and provided great information all compiled in one place.”
Mirshshemi Sahba, QA/QC Director

“Very interactive and thought provoking.”
Lisa Carroll, QA Manager

3. Company-wide Hands-On Education

This session provides actual in-depth practice. The participants are divided into groups. After hearing each stage of the instructional program, they analyze improperly written documents and revise them to reflect your firm’s commitment to quality.

(3-hour session)

“Pragmatic and animated.”
Pasaf Chanton, Assistant Director European Quality“Great group interaction.”
Lilly Tu WWQA VP Biologics

“I wish it were longer.”
Ava Yap, QA Manager

Specifically, participants:

  • Rewrite a memo to assess their writing skills
  • Make presentations to show how the firm employs risk management
  • 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 FDA 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
MASTERS DEGREE PROGRAM AT THE UNIVERSITY OF SOUTHERN CALIFORNIA

“This was very informative. It was lots of fun and an exciting way to learn.”
Mahek Lamephriya, student in the MS program

“I now will think before writing and think before sending.”
Yi Zhao, Reseach Assistant Professor, USC

“I will treat emails more formally.”
Phyllis Tai, post doctorial fellow, UCS

“I now understand the importance of documenting and writing things correctly.”
Rajas Chadanker, Post Doctoral Fellow, USC

“The program was lively, interactive and information.”
Michelle Chu, Quality Engineer

“I enjoyed the learning activities and I will use the communication and diplomatic skills.”
Ankit Shah, MS, BME

COMPLIANCE SYMPOSIA AT HARVARD UNIVERSITY

“I enjoyed the examples provided, and hearing from the other participants.”
Steven Klingerberg, Validation, Baxter Healthcare

4. Coordination and Customization Meetings

Compliance-Alliance can schedule an optional series of individual meetings with key department heads, and the senior compliance team, to ensure that we have a full understanding of the types of issues that might face the company.

(Up to 8 hours)

The instructor’s travel expenses are in addition.

“I appreciated the willingness to entertain attendees’ opinions during the course.”
Steven Johnson, Vice President and Assistant General Counsel, Allergan“It was helpful to learn about the interrelation of documentation and legal proceedings.”
Garry Heidel, Director Regulatory Compliance, Alcon

“I appreciated the basic tips to improve my writing skills.”
Snad Thele, Senior Manager Business Practices, Merck

About the Instructor: Nancy Singer founded Compliance-Alliance LLC to help professionals employed in drug, device and other manufacturing industries establish a culture of compliance. 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.

“Great presentation; useful examples.”
Henry Wroblewski, Regulatory Affairs, Bayer Healthcare


Nancy Singer

Nancy Singer, President, Compliance-Alliance LLC, Former Special Counsel, AdvaMed, Former Attorney, US Department of Justice, Washington, DC 

For questions and information about the “Dangerous Documents” program, contact Nancy Singer at:

nancy@compliance-alliance.com

703-525-4159

Copyright

The slides and written material taught during the course are copyrighted and may not be used without the express permission of Nancy Singer.