Step-by-Step Process for Successful Sterility Failure Investigations

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Thu, Feb 15, 2018
Length
60 minutes
Product Description

FDA Regulations and Guidance on Sterility Failure Investigations


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.

Session Highlights

  • 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

  • QA  and manufacturing staff and management
  • QC lab personnel
  • Microbiologists

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

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...   More Info
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