The EPA’s New Clean Air Initiative for Pharma: Who Will Follow Pfizer?
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And that’s not an empty threat.
The fact that this is the first penalty since the regulations took effect in 2002 does not mean there haven’t been any violations — the EPA simply has not been enforcing the regulations … until now!
In fact, experts say it is the standard operating procedure of the EPA to give an industry sector a grace period to get compliant with new regulations. Once a regional office finds a violation, notice goes out to every office in the country to begin looking for violators. The Pfizer case signals that the pharmaceutical industry is now under an EPA National Enforcement Initiative. Every EPA regional office is now charged with checking on the companies in its jurisdiction.
When the EPA shows up at your facility, will you be ready?
In this 90-minute audioconference, attorney Dennis Arfmann will draw on his vast experience defending clients from EPA enforcement to tell attendees what the National Enforcement Initiative means for them, what to expect from the EPA and how to make sure they are ready.
Sign up your entire team to listen in and discover:
- A detailed explanation of the PharmaMACT regulations, their history and what they mean for drugmakers
- The top five violations that could cost companies the most
- How the EPA begins a National Enforcement Initiative and who they’ll most likely go after
- What the EPA investigators will look for in manufacturing facilities
- 10 tips for creating compliance procedures and following them
- What companies can learn from the Pfizer complaint and settlement
Avoid fines, negative press coverage, high repair costs and the expense of potential shutdowns that can result from violations of the regulations.