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

1. Why Do Companies Like Pharmaceutical Innovations Inc.
Risk the Ultimate Fate – Shutdown by Injunction? –
An Outsider's View
Howard T Cooper

2. 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.

3. 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.
Why Should you Attend:
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

4. Objectives of the Presentation:
The objectives of the presentation are to discuss about:
Quality and compliance concepts
Timeline of events
Product Background and Regulatory History
The WWWHW
What 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 occur
Why did this happen-looking at the total picture and connecting the dots
Playing the devil's advocate role
PRO & CONS
Case Studies-the presenter's experience in consent decree cases
The consent decree experience
What are FDA's primary enforcement objectives and are they effective?

5. Reach us on :
Our links
www.onlinecompliancepanel.com