Step-by-Step Process for Successful Sterility Failure Investigations

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By 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."

When a sterility test failure occurs


here 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.

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.

Areas Covered

•           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 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


Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Danielle DeLucy

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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