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GMP/Quality Auditing
SUPERB CHANCE TO NETWORK WITH QUALITY LEADERS!
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Speaker
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Topic
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Diana Amador-Toro
NJ District Director of the FDA
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Part I. How Pharma Should Monitor itself for GMP Compliance
Part II. How FDA Inspections Could Incorporate PIC/S—Pharmaceutical Inspection Cooperation Scheme
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Nate Manco
Director, US Manufacturing Affairs,
Eco Animal Health
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“Auditor Training for Generic Audit Skills and GMP Regulations”
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Debra Pagano
(Former FDA Pre-Approval Program Manager)
Principal, FDA Consultants LLC
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“Effective Audits”
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Donald Singer
Manager Microbiology North America
GlaxoSmithKline Pharmaceutical R&D
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“Microbiology and Auditing”
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Irwin Silverstein, PhD
Vice-president and Chief Operating Officer, International Pharmaceutical Excipients Auditing
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“Excipient Auditing and IPEA Certification of Excipient Auditors”
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Bob Seltzer
Regulatory Compliance Manager,
GlaxoSmithKline Consumer Health R&D
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“Spotting Inadequate Investigations and CAPAs and overall Weak Quality/GMP Systems”
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Complete Agenda can be found
HERERegistration starts at 7:15 AM. Conference begins at 8:00 AM.
Gov’t & student registrants may inquire for discounts. There will be no refunds for no-shows or cancellation after 05-Jan-2011 (substitute attendees allowed).
Hotel Information:
195 Davidson Avenue
Somerset 08873
Hotel room rate guaranteed @ $99 before tax for block of rooms.
To book a room:
Call Diana Philipova, Catering Manager
Direct Line: 732-584-4613
When & Where
195 Davidson Avenue
Somerset,
08873
Monday, January 10, 2011 from 7:00 AM to 4:45 PM (ET)
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