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August 16th, 2012

FDA: In God we trust, for everyone else, we require documentation


Date: Wednesday, August 22, 2012

Time: 4:30 pm-8:30 pm

Location: 2525 Dupont Drive, Irvine, CA 92612

Registration: (pre-registration required, no walk ins allowed)

Orange County Regulatory Affairs Discussion Group (OCRA) presents…

Dangerous Documentation: Don’t Be Haunted By Your Words

In 2011 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.

During this session, Nancy Singer of Compliance-Alliance, Helene Spencer from ClinReg Consulting Services, Inc. and Dan Solis from FDA will lead a high-energy interactive session. Attendees will be divided into teams; through case studies, real life examples and exercises, they will discover how to ensure that their written correspondence reflects the depth of their organization’s culture of compliance. Specifically, the training will cover:

  • FDA’s expectations for complete and accurate records
  • Top 2011 483 citations relating to documentation
  • How documents can be misconstrued by third parties
  • What to capture and what to ignore in customer complaints
  • Do’s and Don’ts for writing CAPAs
  • Common mistakes in regulatory submissions

Host: Bonnie Safyurtlu, Director, Global Regulatory Affairs, Allergan, Inc.

Speakers: Nancy Singer, President, Compliane-Alliance, LLC, Dan Solis, Director, Import Operations, FDA, Los Angeles District and
Helene Spencer, Consultant, ClinReg Consulting Services, Inc.

Program Manager: Terrie Hopton, BS, CCRP, Manager, Business Development and Special Projects, Promedica International

$50 OCRA Members
$100 Non Members (Includes OCRA 2012 Membership)
$25 Government and Students (Student Rate is for Full-time students only. Student ID and copy of current class schedule required to register).

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