IVT Lab Week Event Combining Method Validation, Laboratory Compliance and Stability Testing
The conference will also feature two FDA presentations: FDA's Final OOS Guidance, presented by Paul Haynie, Compliance Officer, Division of Manufacturing and Product Quality, FDA; and Regulatory Considerations for Stability Testing, presented by Barry Rothman, Senior Compliance Officer, Division of Manufacturing and Product Quality, FDA.
QC Manager of Marketed Biotech Products, Michael Noelchen, attended IVT's Laboratory Compliance conference in London last year, and stated "I feel very confident in the advanced training I received."
"The comprehensive nature of the IVT conference propelled me to volunteer as a future speaker at IVT events, and I am happy to say I am one of the featured speakers at the Lab Week Event in San Diego this October," he said.
The Lab Week Event schedule investigates the industry's most critical issues, with Laboratory Compliance topics including Risk-Based Validation, Designing GMP Training Programs, Managing Risk in the Verification of Standard Methods, Current FDA 483s and Warning Letter Trends.
Method Validation topics covered include FDA/USP Guidances, Analytical Method Transfer, Test Method Validation, LC Method Development with Validation in Mind.
Stability Testing subjects include Risk Management, LIMS, Chamber Temperature and RH Mapping, OOS Investigations for Stability Samples, and Regulatory Requirements.
For more information on this conference or to register, please visit www.labweekevent.com, or contact Advanstar's Customer Service Department at 888-524-9922 (U.S. only) or 218-740-7028.
About the Institute of Validation Technology
The Institute of Validation Technology (www.ivthome.com) is dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries. Through educational publications, timely conferences, and other informational products, The Institute of Validation Technology (IVT) stands alone in its quest to continually advance validation technology and practice, as well as help assure compliance with FDA regulations.
Anne Marie Ricciardi, 732-346-3073
Posted: July 2007
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