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OOS, Out-Of-Specification Laboratory Results

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Category OOS Results, FDA Laboratory Operations, Quality Assurance, Laboratory Analysts Courses, Supervisors checklists, OOS investigations, Quality Assurance functions, laboratory management systems, 2017 laboratory Programs, Online Medical Programs

Deadline: September 12, 2017 | Date: September 13, 2017

Venue/Country: Fremont, U.S.A

Updated: 2017-07-17 15:59:55 (GMT+9)

Call For Papers - CFP


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 investigations

The FDA model for handling OOS investigations

Commonly accepted terminology such as repeat testing and retesting

How the laboratory can meet regulatory expectations for OOS investigations

The interaction between the laboratory and other units in the organization

Who Will Benefit:

Laboratory Managers

Laboratory Supervisors

Laboratory Analysts

Quality Assurance Managers

Quality 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: +1-800-447-9407


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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