There is no one size fits all investigation for microbial contamination. Microbiological testing covers a wide range of products, processes and environments, therefore representative samples from each of these categories forms the basis of what gets investigated. The role of QC microbiology in the identification and investigation of various results from manufacturing areas and finished product testing is extremely important. When the need for an investigation arises, it is common for a cross functional team to convene involving all levels of management from various departments – quality control chemistry and microbiology, manufacturing, quality assurance, and, facilities and engineering.
One of the important elements of the investigation is to decide which failing result comes from the appropriate category: product, process or environment. Once you determine where the failure has occurred, the investigation begins into finding out why it failed and how to correct it.
In this session, expert speaker Danielle DeLucy will describe the actions that should be taken when a sterility test failure occurs. What happens when a suspect microbial result is reported? What does it look like, how do you react? Danielle will answer these questions and review when it is appropriate to investigate a result that may seem out of the ordinary.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Casper E. Uldriks
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous...
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