Preparing and Closing Microbial Investigations – A Review of Industry Practices, Common Mistakes, Risk Analysis and Strategies

Introduction

A key criterion to remain in regulatory compliance is the proper preparation and timely closing of microbiological investigations. This critical report must meet several regulatory concerns. Accurate, timely, correct and implemented microbial investigations are primary ways to avoid 483 citations and warning letters. The successful integration of an investigation program requires risk analysis, regulatory concerns, the manufacturing process, validation status, and knowledge level of staff personnel.

During this live and interactive BenAstrum web training course, the latest industry practices and compliance strategies regarding “root cause” investigations, identification of contamination events, and approaches to timely closing investigation will be presented. A cross functional investigational team approach to closing investigation will also be discussed.

Discussion Points:

• Use of Cause & Effect Diagrams to help pinpoint root causes
• Common mistakes when closing a microbial investigation
• Using laboratory data to help identify the real problem and approach to reducing risk after corrections
• Regulatory issues with delays in closing microbial investigation
• Key quality systems, including change control and training

Learning Benefits:

• Learn regulatory requirements for investigations
• Review various investigation approaches
• Learn how to get to the true “root cause” of any investigation
• How to use  risk analysis tools, process mapping, and cause & effect diagrams
• How to track and trend investigations
• Reviewing corrective actions for compliance

Who Can Benefit:

• Microbiologists
• QA personnel
• Investigational teams
• Change Control personnel
• Managers
• Supervisors
• Validation personnel
• Engineering personnel