[IEEE-bhpjobs] free seminar May 15 - Pilgrim Software

esther L esther-L at mailsnare.net
Sat May 12 12:45:25 EDT 2007


RTP May 15, 8am - 1:45 pm

Knock out non-compliance and avoid 483s. Speeding Compliance Through 
Automation

http://www.pilgrimsoftware.com/events/workshops.shtml

Too often manufacturers believe Regulatory Compliance means discovering 
what the FDA wants us to do . . . the hard way.  No organization wants 
to find itself on the ropes.  Instead, beat the FDA to the punch by 
ensuring your business is fully compliant and avoid becoming a “483” 
statistic.

At this workshop you’ll hear powerful facts, from inside the regulatory 
ring, about the FDA’s current thinking on and expectations for cGMP 
requirements, including compliance recommendations and details about 
laboratory management and control.  Former FDA experts also will weigh 
in on current FDA hot topics, including pre-marketing risk assessment 
and the development and use of risk minimization action plans.  Other 
long-time insiders will address how you can cost-effectively take on 
these challenges, and a leading Life Sciences company will reveal how it 
has applied, pound-for-pound, the most cost-effective solution for 
knocking out non-compliance.


Esther
-- 
-- Esther L.,  esther-L at mailsnare.net or esther-L at alumni.virginia.edu
Speaking only for myself.


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