SUSTAINING COMPLIANCE: How to Implement, Measure, Monitor and Improve Your Systems for Regulatory Co - PowerPoint PPT Presentation

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SUSTAINING COMPLIANCE: How to Implement, Measure, Monitor and Improve Your Systems for Regulatory Co

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Vice President, Compliance & Quality Management. FDA Symposium Day 2 Morning Session ... More than skin deep. Begins with visible intent from the C-suite ... – PowerPoint PPT presentation

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Title: SUSTAINING COMPLIANCE: How to Implement, Measure, Monitor and Improve Your Systems for Regulatory Co


1
SUSTAINING COMPLIANCEHow to Implement, Measure,
Monitor and ImproveYour Systems for Regulatory
CompliancePresented by Robert A.
RhoadesVice President, Compliance Quality
Management FDA Symposium Day 2 Morning
SessionAugust 25, 2005
2
COMPLIANCE IS
  • Well-defined and well-documented processes
  • Well-trained people
  • Consistent and flawless execution
  • never having to say youre sorry!

3
COMPLIANCE IS LEADERSHIP
  • More than skin deep
  • Begins with visible intent from the C-suite
  • Demonstrated through decision-making
  • Not a task abdicated to subordinates
  • More about management than regulations

4
COMPLIANCE IS DATA DRIVEN
  • Systems provide the signals
  • Complaints
  • Audits
  • Investigations
  • OOS
  • Process Deviations
  • TRENDS What is changing? Why?

5
COMPLIANCE IS LISTENING
  • Drowning in a Sea of Data
  • Normal response to being overwhelmed
  • Ignore It!
  • SIMPLIFY
  • Pick 5 key parameters no more
  • Monitor them fiercely!
  • React to them vigorously!

6
FOCUS ON SIMPLICITY
  • Weed your garden with care
  • Non-compliances first cousin is complexity
  • Train your executives to trim business processes
    diligently
  • Non-compliance grows silently, insidiously
  • Daily vigilance
  • Apply same effort and gusto as your avocations!

7
COMPLIANCE IS READINESS
  • Vigilance is only 80 of the game
  • What is your Crisis Plan?
  • Legal arsenal
  • Media management
  • Investigational Response Plan
  • Test
  • Practice
  • Refine

8
  • What surprises are lurking in your operation?
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