Why Do Companies Like Pharmaceutical Innovations Inc. Risk the Ultimate Fate - Shutdown by Injunction? - An Outsider's View

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Why Do Companies Like Pharmaceutical Innovations
Inc. Risk the Ultimate Fate Shutdown by
Injunction? An Outsider's View

• Howard T Cooper

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Description

• This webinar will begin by studying the timeline
  of events in interpreting these events to show
  the chain of actions and their impact leading to
  deteriorating state of control and potential
  injunctive action. The pattern of events will be
  compared to that of other similar situations in
  the FDA regulated environment and their outcomes
  discussed.
• Next, the "What, Where, Who, How, Why" (WWWHW)
  will be more fully explored. Then, the presenter
  will go into a devil's advocate mode to explore
  such questions as what is at the core "principal
  of failure" - compliance dictates, quality
  failures, or combination of both? Is there a
  parallel between the causative factors in the
  pharmaceutical and medical device environments?
  The webinar will also discuss the pros and cons
  of the situation for each side and a discussion
  of the consent decree experience. 

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Why Should you Attend
Who can Benefit
Management and Quality/Compliance will benefit
the most. However, as previously stated, in
today's environment is a matrix with each
function having roles that impact quality and
compliance. By studying how your function role
performed in another company that had major
issues, you can better understand how to prevent
the pitfalls.

• This webinar is designed to make you think about
  your own situation and how your company is
  presently in some state of control. The state of
  control can range from high degree of control to
  low. We'll help you better identify the
  differences between quality and compliance

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The objectives of the presentation are to discuss
aboutQuality and compliance conceptsTimeline
of eventsProduct Background and Regulatory
HistoryThe WWWHWWhat were the events questions?
What standard was not met? Products?Where did
they occur-Brick-And-Mortar, Contract Work, or a
combination?When in the lifecycle did the events
occur?Who allowed these to occur-responsibility?
How did it occurWhy did this happen-looking at
the total picture and connecting the dotsPlaying
the devil's advocate rolePRO CONSCase
Studies-the presenter's experience in consent
decree casesThe consent decree experienceWhat
are FDA's primary enforcement objectives and are
they effective?

• Objectives of the Presentation

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