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KNOCK-OUT NON-COMPLIANCE! - Burlingame, CA
By 16
Jun 10, 2008, 13:26




COMPLIMENTARY EDUCATIONAL WORKSHOP

Burlingame, CA
June 10, 2008

Click Here To Register.


No organization wants to find itself on the ropes. Instead, beat the FDA to the punch this year by ensuring your business is fully compliant and avoid becoming a “483” statistic.
 
At this workshop you’ll learn powerful information from inside the quality, safety and regulatory ring about FDAs expectations; inspections, liabilities and auditing approaches; and innovations in quality, safety and regulatory process improvements. Hear about the latest hot topics in quality and compliance including risk management and supplier controls.
 
Industry heavyweights will coach you on taking on these challenges, and leading FDA-regulated companies will reveal how they have successfully applied a cost-effective solution for knocking out non-compliance for good. Product showcase (optional) presented after lunch.
 
Speakers include:

  • Betty Jones,
    Former FDA Acting Director
    Office of Compliance

  • Linda L. S. Lovett,
    Industry Expert
    Consultant  in strategic and tactical quality assurance leadership in the Medical Device industry

  • Tae Yi
    Associate Director — Quality
    Osmetech Molecular Diagnostic
     
 
Who should attend:
Quality Assurance, Regulatory Affairs, Manufacturing, Operations, IT, Compliance



Location:
Hyatt Regency
1333 Bayshore Hwy
Burlingame, CA 94010
(650) 347-1234
Click here for hotel information.

Cost:
Complimentary

On-site Registration:
Starting at 8:00 am



Tentative Agenda

  8:00 am      Continental Breakfast
  9:00 am      Welcome
  9:15 am      The FDA’s Perspective on Quality and Compliance
10:15 am      Implementing Quality Plans and Systems
11:15 am      Case Study
12:00 pm      Automated Solutions
12:30 pm      Lunch
  1:30 pm      Live Demo of an
                     Automated Enterprise Quality and Compliance Solution



For more information or questions regarding this workshop, please contact Nancy Defilippis at defilippisn@pilgrimsoftware.com.

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