Webinar Includes : All the training handouts , certificate ,Q/A and 120 mins Live Webinar

Join us for a webinar on December 03 for a discussion of the webinar

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

Webinar Takeaway

  • 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

Overview

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.

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.

Faculty John G. Lanese

Faculty John G. Lanese

30+ yrs exp.

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.

Choose a Purchase Option


$249

Live Webinar - Single Participant 120-mins

You get one log-in for the live 120-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$499

Group Up to 5 Participants ( MP3 Download Free )

You get 5 log-in for the live 120-minute webinar for all the participant, presentation materials ,DVD , and the opportunity to ask questions by phone and email

$359

Recorded Access Corporate Group

You'll have Group access to log-in for an archived recording of the entire 120-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$389

Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.

$399

Live + Recorded Access

You get one log-in for the live & recorded 120-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email