The FDA auditor is coming tomorrow. What can you do to make sure your documents are ready?
To answer questions such as this one, WIB-Capital Region and event sponsor Sterne, Kessler, Goldstein and Fox, LLP (SKGF), hosted a July 21, 2016, seminar entitled “Dangerous Documents: Avoiding Land Mines in Your FDA Records and e-Mails.” The event speaker was Nancy Singer, Esq., founder of the Compliance-Alliance, LLC, and she discussed how to establish a culture of compliance to ensure that documents in your purview won’t come back to bite you during an audit or a trial.
Event attendees ranged from paralegals to Directors at SKGF, academics, and industry professionals from around the region. Nancy reminded them that drug and device executives are held to a higher legal standard because the consumers using their products are not in a position to decide complex scientific questions themselves. During the seminar attendees also completed group exercises where Nancy helped us realize how statements and actions that many are guilty of can come back and cause great harm personally and professionally.
The advice she shared is extremely useful to those responsible for protecting sensitive information for their clients and organizations. Nancy recommended daily habits for us all in order to achieve a culture of compliance:
- Don’t sign things you don’t read.
- Pause before sending an email.
- Don’t put opinions or inflammatory words in correspondence or email.
- Never send e-mails when angry.
These suggestions sound simple, but she offered several recent examples of how not following these simple rules have resulted in serious legal troubles for individuals and corporations.
Nancy began and ended the seminar with the simple message that “Documents are like diamonds: They are very precious and they last forever.”
For more information about the Compliance-Alliance visit their website.
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