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PharmaMedDevice

March 26-28, 2008
Philadelphia, PA
Exhibitor: Booth #4907
Click here for details.



PANEL DISCUSSION

Title:

"Improving Quality and Compliance through Internal and Supplier Audits"

Date:

March 26, 2008

Time:
10:00 AM - 11:30 AM

Location:
110AB

Description:
Many firms feel that they are adequately auditing and managing their operations and suppliers yet find they are having myriads of quality issues. FDA and other auditing organizations are going to focus on auditing processes, especially supplier audits, in 2008. With this focus, FDA is going to heavily write firms up for GMP violations. Repeated FDA 483's can lead to warning letters, seizures or even jail time. World-class manufacturers need to make significant investments in systems and processes to improve their internal and supplier quality audits. This panel discussion will cover auditing and management techniques in relation to quality and compliance and how a manufacturer can assure a consistent state-of-control.


Speakers:

Christopher Delporte

Managing Editor, MPO Magazine

Nikki Willett
Vice President Marketing and Regulatory Products, Pilgrim Software

Linda Lovett
Director of Quality, Medtronic Spinal and Biologics

Eize de Boer
Global Manager Life Science Auditing, SGS, Inc.

Robert Dicheck
Vice President QA/RA, Osmetech

Roland Cooke
Regulatory Services Specialist, SGS, Inc.



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