3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

Join us for a webinar on February 24 for a discussion of the webinar

• QA managers and personnel
• Analysts and lab managers
• CAPA management
• Regulatory affairs
• Training departments

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

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.

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.

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 15 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.