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

Live, Interactive Training Webinar

Date: Wednesday December 19, 2018
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Jerry Lanese Ph.D. Biography>>>

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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.

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.

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*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM The requirement for Laboratory OOS investigations,
The Laboratory investigation – Phase I,
The Laboratory investigation – Phase II,
Identification of the cause of the OOS,
10:30 AM Break
10:40 AM Retesting,
Reporting to QA,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

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

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

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

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Instructor: John G. (Jerry) Lanese Ph.D.

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… Full Bio>>>

 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland