Event Date/Time: Oct 16, 2000 End Date/Time: Oct 17, 2000
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CBI is pleased to announce a new addition to its Pharmaceutical Conference Series, OOS [Out-of-Specification Test Results] - A Step by Step FDA Guidance Clarification for Conducting a Thorough OOS Investigation (October 16-17, 2000) FDA regulations require an investigation be conducted whenever an OOS test result is obtained. Even if a batch or material is rejected based on an OOS result, an investigation is necessary to determine if the result is related to manufacturing process or analytical discrepancies. Attend this conference to learn how to avoid 483 warning letter that costs you time and money in re-testing and re-sampling. Understand the FDA draft guidance and its impact on labs. Develop tools to analyze and identify the source of OOS test results. Employ methods for statistical treatment of analytical results. Prevent regulatory action with thorough investigation reports of non-conformance and OOS. Develop corrective follow up actions for OOS test results. Prepare for an OOS audit to avoid warning letters and understand ISO/IEC 17025 - the international standard for accrediting testing and calibration laboratories. Experts reveal their strategies for preventing and handling OOS within FDA Guidelines: DuPont Pharmaceuticals, GelTex Pharmaceuticals, Merck Research Laboratories, Oread, Schein Pharmaceuticals, SmithKline Beecham and SP Pharmaceuticals. Plus attend the half-day workshop to learn how to implement effective SOPs for conducting meaningful OOS investigations and how to write a concise and effective investigation report to avoid 483s. For more information or to register, call 800-817-8601 or email cbireg@cbinet.com.


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