This seminar 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.
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.
Learning Objectives:
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)
Areas Covered in the Session :
Session 1:
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
Checklists
Fishbone Diagrams
Session 2:
Testing the hypotheses regarding potential root causes
Retesting
Considering Other Batches
Session 3:
Developing a proper CAPA plan to address any Corrective Actions
How to properly document findings
Example of a proper OOS investigation write up
Who Should Attend:
Quality Assurance Departments
Quality Control Departments
Research and Development Departments
Regulatory Affairs Departments
Compliance Departments
Laboratory Staff
Training Departments
GMP auditors
Consultants