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.
August 14, 2020
10:00 AM PDT | 01:00 PM EDT
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Product Id : 503275
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
Why should you Attend:
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
Most companies have procedures but either they are not adequate or are not followed. This webinar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.
Areas Covered in the Session:
Learning Objectives :
- FDA requirements for handling OOS/ OOT results
- Phase I- Laboratory Phase of Investigations
- Phase II a Full Scale Investigation
- Concluding an Investigation
- Out-of Trend investigations
- Common pitfalls during OOS Investigations
- Review of recent OOS related citations in Warning Letters
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)
- QA Managers and Personnel
- Analysts and Lab Managers
- CAPA Management
- Regulatory Affairs
- 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.