Handling OOS Test Results and Completing Robust Investigations
This 90-minute accredited course is designed to provide sound training on how to recognize and investigate a typical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations, This webinar will help explain how the 21st Century Cures Act will impact the current pharmaceutical and medical device industries, particularly their processes for new product and new product indication requests.
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This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).
Why should you Attend:
This 90-minute accredited course is designed to provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
Areas Covered in the Session:
- Guidelines for Detecting an OOS or Atypical Result
- Definition Atypical or Out of Specification Result?
- Review of the FDA Guidance for Industry on
Investigating OOS Test Results
- Phase I: Initial Laboratory Investigation
- Phase II: Full Scale Investigation
- Root Cause Analysis Methods
- 5 Whys
- Flow Charts
- Fishbone Diagrams
- Testing the Hypotheses Regarding Potential Root Causes
- Considering Other Batches
- Developing a Proper CAPA Plan to Address Any Corrective Actions
- How to Properly Document Findings
- Example of a Proper OOS Investigation Write Up
Who Will Benefit:
- Learn the responsibilities of analysts and supervisors
- Listen to what the FDA looks for in terms of human errors
- Describe when a full investigation should be triggered
- Describe the frequency for re-testing and re-sampling
- Learn how to implement the corrective and preventive action plans (CAPA)
- Lab Analysts
- Supervisors and Managers in Pharmaceutical or Biological Laboratories
- Regulatory Affairs
- GMP Auditors
- Quality control and Quality Assurance Personnel responsible for Generating or Evaluating test results in a regulated Environment
- Training Departments
Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.