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.
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:
Why Should you Attend
- 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
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.
Who will Benefit
- 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
The following personnel in pharmaceutical laboratories will benefit from this training:
- 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