Performing Microbial Data Deviation Investigations in the Pharmaceutical Industry Training Course

Microbial data deviation investigations (MDDIs) are notoriously difficult to perform for even the most experienced investigators. MDDIs often focus on an event that has occurred several days or weeks in the past and direct evidence for the root cause is usually rare. As a result, investigators often have only circumstantial evidence and historical data to rely on when attempting to piece together a comprehensive analysis of the root cause.

This practical, interactive training course will utilize real-life scenarios and examples to guide attendees through the investigative process. They will begin with how to provide timely and appropriate notification when a MDDI occurs followed by how to perform effective laboratory and manufacturing investigations, utilize techniques for robust root cause analyses and batch impact assessments, and determine and implement appropriate and effective Corrective and Preventative Action (CAPA).

Attendees will also learn important pitfalls to avoid that can prevent determination of the root cause and how to document an investigation properly and objectively without bias. Attendees will leave with a better understanding of the unique aspects of MDDIs and an improved skill set that will allow them to better address MDDIs, thus increasing their investigational success rate.

Upon completion of this training course, the attendee will be able to:

• Understand the unique aspects of Microbial Data Deviation Investigations (MDDIs) and how to work through them
• Establish and lead a comprehensive investigation team
• Know how to gain support from key players and stakeholders when needed
• Conduct thorough laboratory investigations that will facilitate the subsequent manufacturing investigations
• Justify and utilize common tools for root cause analysis
• Execute robust root cause analysis and establish appropriate, effective Corrective and Preventative Action (CAPA)
• Recognize pitfalls that can derail an investigation and prevent discovery of the definitive root cause
• Perform comprehensive batch impact analysis
• Scientifically support decisions and conclusions without bias
• Thoroughly and objectively document an investigation
• Effectively frame and present the investigation to an audience

For more options and/or related training courses, please visit the following page(s):

• PDA Environmental Monitoring Training Courses