Inadequate procedures for laboratory out-of-specification (OOS) investigations remains high on the list of FDA observations. Although the FDA's interest in how pharmaceutical firms handle OOS laboratory results began more than 15 years ago, and the Agency 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 audio conference we discuss the investigation that goes on within the laboratory. Although the focus is on the FDA guidance, the discussion includes suggestions for a process that will meet the FDA expectations.

This audio conference covers:

• 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 and retesting
• Confirmation of the OOS observation
• Reporting the investigation to Quality Assurance

About the speaker:

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 on 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.

Who should attend?

• Quality Control Managers & Supervisors
• Quality Control Analysts
• Quality Control Record Reviewers
• Quality Assurance Managers & Supervisors
• Quality Assurance Record Reviewers