Available Courses

• Documenting and Conducting OOS Investigations
  March 2-3, 2009
  In an FDA regulated environment, accurate and thorough investigation is a critical response for out of specification (OOS) laboratory test results. The challenge is to capture necessary information in a timely fashion from a diverse workforce of individuals with technical and non-technical backgrounds. This course provides a process to overcome that challenge, integrating FDA requirements and guidelines that focus on effective documentation, data collection, and the understandable language necessary for successful investigations.
  
  
• Validation of Microbiological Test Methods
  March 2-3, 2009
  The course is designed to assist in the validation of test methods using a step-by-step procedure for manual techniques, automated microbiological systems and rapid methods.
  
  
• Managing Quality Systems
  March 2-4, 2009
  This is a highly interactive hands-on workshop designed to give personnel responsible for managing Quality Systems an in-depth examination of how to assess, design and implement Quality Systems.
  
  
• FDA Inspection Readiness for a Training Systems Audit
  March 4, 2009
  This course will provide a sequential, step-by-step process to prepare for auditing a training function as part of a Quality Systems audit, including documentation, record review and training metrics.