Institute of Validation Technology has announced its Lab Week event - a three-day conference providing a comprehensive guide to method validation, laboratory compliance, and stability testing
Lab Week will take place in San Diego, USA, from 2-5 October 2007 and will feature more than 40 presentations from industry leaders, including Patrick Bell of Wyeth Pharmaceuticals; Ludwig Huber of Agilent Technologies; and Barry Scheer of Bristol-Myers Squibb.
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 Lab Week in San Diego this October", he said.
The Lab Week schedule explores the industry's most critical issues, with laboratory compliance topics including risk-based validation, designing GMP training programmes, 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.
