Sterility Failure Investigations – A Step-by-Step Process for Success

Product Id : FDA115
Instructor : Danielle DeLucy
Apr 18, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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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.

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.

Learning Objectives:

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, 90-minute 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 Wil Benefit:

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 & Microbiology
  • Manufacturing
  • Quality Assurance
  • Facilities & Engineering
Speaker Profile:

Danielle DeLucy,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.


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