Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations

Website https://worldcomplianceseminars.com/upcoming_webinar | Edit Freely

Category Electronic document system, Functional, QA managers, Lean Project

Deadline: February 06, 2020 | Date: February 06, 2020

Venue/Country: Online Webinar, U.S.A

Updated: 2020-01-04 18:20:22 (GMT+9)

Call For Papers - CFP

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely.

This Live Webinar Will Cover:

-The requirements for laboratory OOS investigations.

-Latest Regulatory expectations.

-The laboratory OOS investigation process.

-Laboratory investigation, Phase I.

-Laboratory investigation, Phase II.

-Retesting.

-Resampling.

-Communicating with Quality Assurance.

Speaker

John G. (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