Seminar Details

Title: Best Practices: Handling Out-of-Specification (OOS) Investigation and Properly Documenting Laboratory Investigation Reports.

Speaker : Glen Feye, M.S., CQE is the President of Accurate Consultants, Inc.

Date : January 20th, 2010

In 2006, FDA published the long awaited Final Guidance-Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.  This guidance document provides an overview of an optimal OOS investigational process for when laboratory results are found to be outside of pre-defined specification limits. Still firms are continually faced with FDA 483s, since FDA Investigators still observe the use non compliant OOS procedures exist, firms not following their procedure and firms are unable to defend their laboratory investigations, conclusions, and corrective actions. 

 After purchasing the audio recording/PDF transcript the following will be received

• The link to the mp3 download(CD's can be emailed upon request) 
• PDF Transcript of the recording 

Seminar Details 

Title: Best Practices: Best Practices: Managing cGMP Formal Failure Investigations and the Closed Loop CAPA System 

Speaker : Glen Feye, M.S., CQE is the President of Accurate Consultants, Inc.

Date : February 20th, 2010

During FDA audits, Investigators are continuing to review failure investigation reports and evaluate the effectiveness of the FDA regulated firm’s CAPA System. FDA audits the firm’s procedures and failure investigation documentation and pays close attention the firm’s ability to identify, investigate, and correct unexpected issues in a timely manner. The firm must also demonstrate that their corrective actives were effective so the issue does not reoccur and product was not impacted. Still firms are continually faced with FDA 483s, since FDA Investigators still observe the use non compliant Failure Investigation and CAPA procedures, firms not following their procedure, as well as firms are unable to defend their investigations, conclusions, and corrective actions.  

After purchasing the audio recording/PDF transcript the following will be received

• The link to the mp3 download(CD's can be emailed upon request) 
• PDF Transcript of the recording