Call-in teleconferencing
Video demonstrations included in the presentation

Sterility Test Failure Investigations

April 18, 2016 WEBINAR
12:00pm - 1:30pm EDT

The sterility test is a critical lot release component for the manufacturing of sterile products.  When sterility test positives are observed, a thorough and formal investigation is required.  The compendial sterility test methodologies are harmonized for the United States, Europe and Japan.  This harmonized compendial method offers guidance on how to conduct sterility test investigations.  In addition, the FDA’s guidance document for aseptic processing, Guidance for Industry:  Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, provides guidance on conducting a sterility test failure investigation.  This course will describe the actions that should be taken when a sterility test failure occurs.  In this course we will discuss:

  • Sterility Test Failure Investigation Regulations and Guidance
  • Sterility Test Failure Actions to be Taken
  • How to Conduct Thorough Sterility Test Failure Investigations
  • Risk Analysis Tools for Root Cause Determination
  • Lab Investigation and Manufacturing Area Investigation Steps
  • Impact to Affected Production Lots
  • Investigation Timeliness
  • How to Best Document the Investigation
$385 for one person
$700 2-5 people
$999 6-10 people
Instructor:    Marsha Stabler Hardiman  

Marsha Stabler Hardiman has over 20 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields.  Marsha has a Bachelors in Biology from Western New England University in Springfield, MA.  Marsha is an expert in industrial Microbiology test methods from environmental monitoring (EM) and utility system microbial testing to intermediate product testing through final product sterility testing.  Marsha also served as a Microbiology Expert - Notified Body regulatory inspector for CE certification of medical devices and has extensive knowledge in quality systems.  Over her career, Marsha has established numerous EM programs for many different medical device and pharmaceutical companies. 

Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board and Education Advisory Board; is leading a PDA Task Force on Microbial Investigations; serves on the PDA Microbiology Meeting Planning Committee and has been the chair of the PDA Annual Meeting. 

Marsha is a Senior Consultant for ValSource and in this role helps companies implement quality risk management into their quality management systems and validation programs.  Marsha currently helps companies develop risk based environmental monitoring programs.