Fda Guidance On Retests

Laboratory Investigation Out-of-Specification Results

Why Should You Attend:  Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion.

There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this webinar we will discuss the investigation that goes on within the laboratory. Although the focus will be on the FDA Guidance, the discussion will include suggestions for a process that will meet the FDA expectations.

Areas Covered in the Seminar:

Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other). US. 21CFR211.160 FDA Guidance to the Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production ICH. Q7; 11.1 Canada. C.02.015

Key Points in the Presentation:

What constitutes an OOS observation. The guidance process. Steps to be taken in the laboratory in the event of an OOS observation. The initial laboratory investigation. Repeat testing. Retesting. Confirmation of the OOS Observation. Reporting the investigation to Quality Assurance. John G. (Jerry) Lanese , PH.D. CMC is the President of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.

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