Dangerous Documents: How to Avoid Land Mines in Your FDA Documents and Emails | In Person Workshop | Singer

Dangerous Documents: How to Avoid Land Mines in Your FDA Documents and Emails | In Person Workshop | Singer

March 20th, 2013 // 1:07 pm @ jmpickett

Dangerous Documents: Avoiding Land Mines in Your Emails and Documents is a absolutely unique all day, in person event with former DOJ prosecutor Nancy Singer – where you will discover the potential consequences of writing emails and other documents that are inappropriate.

After this in person, all day workshop event, 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 surprises.

To Inquire About Hosting This All Day Workshop, contact us!

“Dangerous Documents” has been presented to rave reviews at many major pharmaceutical firms, including:
– Medtronic
– Siemens
– Allergan
– Bayer
– Zimmer

Testimonials:

MEDTRONIC

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

“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

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

“I will write fewer emails and use more direct communication.”
– Al Beatrez, Commercial Release Manager

“I will not leave blanks in forms.”
– Stephanie Elhard, Senior Safety Manager

“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

“I will look at what I write from an outsider’s perspective who is trying to tell a story.”
– Jenn Dolan, Technical Sourcing Specialist

To Inquire About Hosting This All Day Workshop, contact us!

SIEMENS

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

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

“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 Manager Technical Siemens

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

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

“Very pertinent to our work.”
– Teresa Kuan, Manager WWQA

“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

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, Research Assistant Professor, USC

“I will treat emails more formally.”
– Phyllis Tai, Post Doctoral Fellow, USC

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

“The program was lively, interactive and informative.”
– 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

“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

“Great presentation; useful examples.”
– Henry Wroblewski, Regulatory Affairs, Bayer Health care

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.

To Inquire About Hosting This All Day Workshop, contact us!

There are 3 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.

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.

3. Company-Wide Hands-On Education

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

To Inquire About Hosting This All Day Workshop, contact us!

Overview:

“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.

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.

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.

Industry leaders like Pfizer, Bayer, Chevron 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?”

All of your employees must know how to write emails and other documents that are complete and accurate and do not create land mines.

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.

To Inquire About Hosting This All Day Workshop, contact us!