Step-by-Step Process for Successful Sterility Failure Investigations

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Step-by-Step Process for Successful Sterility Failure Investigations

Step-by-Step Process for Successful Sterility Failure Investigations

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About this event

  • 1 hour 30 minutes
  • Mobile eTicket

Date: Feb 21, 2023

Time: 1 PM EST

Duration: 90 Mins.

Level: Intermediate to Advanced

Group Packages: Please contact


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.

Objectives of the Presentation

  • 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

Why Should you Attend

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, our speaker 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 will Benefit

  • QA and manufacturing staff and management
  • QC lab personnel
  • Microbiologists
  • Quality Control
  • Sterility Assurance
  • Manufacturing/Production
  • Senior Management
  • Raw Materials Tester
  • Supplier Quality
  • Regulatory Affairs
  • Quality Assurance
  • Compliance
  • Design Engineers
  • Facility, Maintenance and Engineering
  • Contract Manufacturing Organizations (CMO)
  • Active Pharmaceutical Ingredients Suppliers
  • Chemical Suppliers
  • Excipient Suppliers

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.