Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar
Who Will Benefit
- QA managers and personnel
- Analysts and lab managers
- CAPA management
- Regulatory affairs
- Training departments
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
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 seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.
Industries who can attend
This 3 Hours Webinar -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.