Step-by-Step Process for Successful Sterility Failure Investigations

There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As such, there is no one size fits all investigation.

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.

Why You Should Attend:

Medical device regulations in the US and the EU are foundational to the remainder of the regulations that are applied to medical devices throughout the world. An inspection by a representative of a regulatory body or a complaint from the market could uncover regulatory violations that may result in sanctions of various levels of seriousness. These sanctions could result in diminished reputation, device recalls, extended intrusive monitoring, and/or civil and criminal penalties.

It is important to understand how regulatory agencies in both the US and the EU are structured and function and the specific medical device regulations within each jurisdiction that apply to maintain sound medical device compliance.

Now, with the EU’s new Medical Device Regulation of over 400 pages soon to be law and the complexities of medical device regulations in the US, it is critical to effective regulatory compliance that all levels of management all along the supply chain, understand how the process works and have at least a basic understanding of the key regulations and their contents.

Areas Covered in the Session :

This course 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, and how should you react? This webinar will review when it is appropriate to investigate a result that may seem “out of the ordinary.”

By attending this interactive session, you will learn:

  • FDA Regulations and Guidance on Sterility Failure Investigations
  • Stages of Investigation: Lab Investigation vs. Manufacturing Investigation
  • Tools to use to help determine Root Cause
  • How to categorize sterility results
  • How to address impact to lots affected
  • Areas, parameters and variables to investigate as part of the investigation
  • Proper documentation of the Investigation
  • CAPA plans that address root cause
Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Facilities & Engineering Departments
  • Chemistry & Microbiology Departments


Danielle DeLucy

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 filling and packaging operations.

Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection.

Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.



  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance