Performing Microbial Data Deviation Investigations in the Pharmaceutical Industry Training Course (PDA 620)

OVERVIEW

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. We shall begin with how to provide timely and appropriate notification when a MDD occurs followed by how to perform effective laboratory and manufacturing investigations, techniques for robust root cause analyses and batch impact assessments and finally, determination and implementation of appropriate and effective CAPA.

Attendees will also learn important pitfalls to avoid, that can prevent determination of the root cause and how to properly and objectively document an investigation 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 them, thus increasing their investigational success rate.

LEARNING OBJECTIVES

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

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

WHO SHOULD ATTEND

This event is intended for professionals who are involved in leading, supporting, and/or reviewing Microbial Data Deviation Investigations for either sterile or non-sterile operations in the Pharmaceutical Industry.

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