Setting Up a Program to Avoid Dangerous, Damaging Documents

Wednesday, March 24, 2010

National Harbor, MD (Washington, DC Metro Area) | The Gaylord National


In 2008 over 87% of FDA warning letter citations involved record deficiencies. FDA officials say, "If you didn't document it, it didn't happen. In God we trust, for everyone else we require documentation."

Every document that is written on a company computer during company time becomes a company record. As a result of multi-million dollar lawsuits, industry leaders have learned that a seemingly innocuous phrase like, "This will negatively impact the bottom line." in an email from an employee can undermine their organization’s credibility. The thousands of emails sent on a daily basis can be retrieved indefinitely. In this hands-on program led by industry expert, Nancy Singer (formerly a prosecutor and defense lawyer), you will have opportunity to analyze improperly written documents and revise them to reflect your firm's commitment to quality. You will get ideas on how to set up a training program to avoid dangerous, damaging documents in your organization.

Co-sponsored with:

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Who Should Attend

QA/RA/Clinical Officials - Training Officers - Compliance Officers


Registration
AdvaMed Member $350 Register Now
Non-Member $450

Agenda Overview
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  • Who can be held criminally liable under the law
  • How the scope of your authority determines your legal liability
  • What FDA investigators look for when reviewing documents
  • The risks of leaving blanks in required records
  • How to distinguish between fact and opinion
  • When to avoid writing opinions on FDA regulatory matters
  • The dangers in not monitoring employees emails
  • Types of information never to include in documents
  • Words that will attract the attention of prosecutors or plaintiff's lawyers
  • Why it is crucial to follow a document retention program
  • How to set up a program to avoid dangerous, damaging documents

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Speakers

Nancy Singer, President, Compliance-Alliance (Former prosecutor and defense attorney)
Tom Maeder, Executive Director, MTLI, AdvaMed (Author and Science Writer)

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General Information

It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here.  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.


For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

CANCELLATION & REFUND POLICY

All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a 10 percent cancellation fee. There will be NO REFUNDS for cancellations received within the 10 business days prior to the start of the program including "no shows".

We welcome substitutions in lieu of cancellations at any time. Please contact Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.  Topics and speakers are subject ot change without notice.  Advamed reserves the right to cancel or reschedule any program, whereupon full registration feew will be refunded or applied to the rescheduled program in accordance with the registrant's preference.  In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.

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Location Information
The Gaylord National Hotel
201 Waterfront Street
National Harbor, MD 20745
301-749-2073

A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $218.  Please make your reservations by contacting the hotel at 301-965-4000 and identifying yourself as a member of the Advanced Medical Technology Association room block.  This rate will be available until February 20, 2010.  Room and rates are subject to availability after this date.  Please make your reservations early as the block will fill up quickly.

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Frequently Asked Questions

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