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

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

This live training webinar includes the following for each registered attendee: • A copy of the presentation slides • A copy of the Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production • A certificate of participation for attendee training records

" John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System"

Develop an understanding of how a compliant laboratory handles the investigation


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. 

The objective of this live training webinar is to develop an understanding of how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation process. The interactive live discussion will be based on the FDA guidance on handling OOS laboratory results and to provide a clear process for compliant laboratory OOS investigations.

Areas Covered

•      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.

Learning Benefits:

•      Understand the developing expectation for appropriate OOS investigations. 
•      Understand of the expectation for the identification of the cause of the OOS results.
•      Gain a clear insight of the laboratory OOS investigation process.
•      Learn the terminology associated with laboratory OOS investigations.
•      Learn about outlier testing.
•      Understand how the OOS laboratory investigation process relates to the general expectation for deviation                  investigation.

Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other):

•      US - 21CFR211.160, 192
•      ICH Q7; 11.1
•      FDA Guidance for the Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical                    Production

Webinar outline and time breakdown: 

Time 10:15 AMLog In Period10:30 AM
Introduction10:40 AM
The requirement for Laboratory OOS investigations,The Laboratory investigation – 
Phase I
The Laboratory investigation 
Phase II
Identification of the cause of the OOS
11:30 AMBreak11:40 AM
Retesting,Reporting to QA
12:30 PM
Live Questions & Discussion

Who will Benefit

The following individuals or disciplines will benefit from attending this Webinar:

•      Senior management
•      Production management
•      Quality management
•      Quality Assurance
•      Quality Assurance Product Reviewers
•      Regulatory

Industries who can attend

This 120-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

John G. Lanese

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. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry

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