Step-by-Step Process for Successful Sterility Failure Investigations
A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.
Instructor
Danielle DeLucy
Pharmaceutical Quality & Microbiology Consultant
What You'll Learn
About the event
About this event
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. 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.
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.
This course will describe the actions that should be taken when a sterility test failure occurs, covering FDA Regulations, stages of investigation, tools for root cause determination, and CAPA plans that ensure regulatory compliance.
Code: FDB2465
Curriculum
Requirements
- Quality Assurance, QC, Manufacturing, or Microbiology professionals
- Applicable to pharmaceutical, biologics, and sterile product manufacturing environments
Meet Your Instructor
Danielle DeLucy
Pharmaceutical Quality & Microbiology Consultant
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 clients. In the years after, she held positions in quality management while increasing her responsibility. She has helped lead many Regulatory Health Inspections and was instrumental in coaching peers prior to inspections. Currently, Danielle assists companies faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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