Event Detail
Out-of-Specification Investigations – Beyond the laboratory
March 18, 2010
- Palo Alto CA UNITED STATES
ComplianceOnline
This Out-of-Specification Investigations webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization. Why Should You Attend : Although the Barr Decision of the early 1990s surfaced the concern about out-of-specification results and investigations, many organizations have not determined how to effectively address the issue. Out-of-specification results bring out many reactions in the pharmaceutical firm: .emotional, political, finger pointing, denial. There inhibit a productive investigation and a timely conclusion of the investigation. There is still confusion in the pharmaceutical firm as to how to handle that is demonstrated to be out-of-specification. The webinar participants will learn the origin of the term out of specification and FDA concerns and opinions. They will be led through a process for the successful completion of OOS investigations. The webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization. The involvement of QA, Production, Packaging, Materials Management and Quality Control will be discussed. Areas Covered in the Seminar: * Introduction. * Terminology. * The confirmed out-of-specification result. * The investigation team. * Review of batch records. * Review of materials. * Investigation report. * Corrective action. * Preventive action. Who Will Benefit: