OOS, Out-Of-Specification Laboratory Results
- Start Date:
- Wednesday, 13 September, 2017
- End Date:
- Wednesday, 13 September, 2017 11:30am
- Health & Nutrition
Overview:The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. Why should you Attend:All Laboratory and Quality Assurance management, analysts and reviewers should be aware of the FDA expectations for procedures that define a complete, scientifically sound investigation of each out-of-specification and out-of-trend laboratory observation and evidence that laboratory personnel are following the procedures.
Areas Covered in the Session:Why the regulators are concerned about the handling of OOS investigationsThe FDA model for handling OOS investigationsCommonly accepted terminology such as repeat testing and retestingHow the laboratory can meet regulatory expectations for OOS investigationsThe interaction between the laboratory and other units in the organization Who Will Benefit:Laboratory ManagersLaboratory SupervisorsLaboratory AnalystsQuality Assurance ManagersQuality Assurance Record Reviewers Speaker Profile:John (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System.
He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions. Event Cost & Details:One Dial-in One Attendee Price: US$150.00 Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Netzealous LLC DBA - Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- Netzealous LLC DBA - Compliance4All