Troubleshooting OOS or Unexpected Dissolution Results - An Advanced Course Using Root Cause Analysis with the Ten Most Common Causes

Duration: 90 Minutes
Investigations into unexpected results are usually time consuming and fraught with anxiety, as well as being subject to Regulatory inspection. Using a Root Cause Analysis approach can reduce the time necessary to complete the investigation and simultaneously help, by pointing to appropriate Corrective and Preventive Action (CAPA) reduce the probability that additional OOS results from the same cause will be observed.
OOS Investigations
Instructor: Gregory Martin
Product ID: 504130
This webinar will point out some of the goals of effective investigations, and how you can use Root Cause Analysis and Corrective and Preventive Actions to accomplish these goals.

Objectives of the Presentation
Upon completion of this course the learner should be able to:
  • Respond appropriately to different types of OOS or other unexpected dissolution results
  • Understand USP staged testing for dissolution, and how to apply it when undesired results are generated
  • Devise a strategy for investigations that will lead to root cause identification
  • Be familiar with some of the common causes of undesired dissolution results
  • Be able to document the investigation, including batch disposition and CAPA, in a manner that is consistent with FDA expectations
Why Should you Attend
Generating out of specification (OOS) or unexpected dissolution results generally triggers a flurry of activity and creates anxiety in the lab. What are the implications of the results? What caused them? How can we keep this from happening again?

This course offers a methodical approach to evaluate whether the result truly represents a product failure and a troubleshooting guide to aid in identifying the root cause of the problem, which have proven useful for many practitioners in the dissolution field.

Areas Covered
  • What constitutes an OOS or unexpected dissolution result?
  • How USP does staged testing influence next steps?
  • The basic strategy for investigating undesired dissolution results
  • Determining the Root Cause
  • General investigation procedure
  • Troubleshooting undesired dissolution results: learning from others experiences
  • Documenting the investigation
  • Batch disposition/CAPA
  • Attendee questions
Who will Benefit
The following personnel in pharmaceutical laboratories will benefit from this training:
  • Chemists
  • Supervisors and Managers (Innovator and Generic companies for Human and Animal products, Dietary Supplements and associated Contract organizations)
  • Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
  • Quality Control and Research
  • Analysts and other laboratory staff
  • Regulatory Affairs
$375
Recorded Session for one participant
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  $500.00 Training CD
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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