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Performing Effective and Compliant Sterility Failure Investigations

Duration : 90 Minutes

Joy L. McElroy,

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more


This webinar program will disclose how to prevent mistakes by implementing a robust CAPA program. Errors and inaccuracies made when corrective and preventative actions are not clearly recognized and applied during sterility test failure investigation will be discussed. Many times ineffective investigational procedures and tools are used to conduct a sterility test failure investigations. The webinar will also explain how avoiding common mistakes will ensure that manufacturers meet the sterility requirements USP <71> and other regulatory guidelines applicable to their finished products, bulk drug substance, raw materials or excipients.

Why Should You Attend:

In this webinar our expert speaker Joy Mcelroy, will discuss the Impact of sterility failure investigation for commercially distributed products under a stability testing program.

Course Objectives:

The objective of this webinar is to provide an understanding of the regulations for sterility testing programs and the process of conducting an effective, robust and compliant sterility test investigations for various types of products. The content of a sterility test investigation form will be shared with the attendees as a tool that may be used when designing a sterility failure investigation program.

Course Outline:

•  Regulations guiding manufactured product sterility testing and how to ensure adherence to program testing requirements.
•  Conducting sterility test failure investigations and what to look for during investigation process.
•  Role of contamination such as microbial identification of contaminants and its importance.
•  Retest during a sterility failure investigation and how to apply corrective and preventative actions based on a sterility failure investigation.
•  Dispositioning impacted products based on investigational findings while avoiding common mistakes during product disposition.

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

•  Quality Control Managers
•  Quality Assurance
•  Manufacturing/Production Operators
•  Senior Management
•  Supplier Quality
•  Regulatory Affairs
•  Quality Control Analysts
•  Facility, Maintenance and Engineering Personnel
•  Consultants

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

100% MONEY BACK GUARANTEED

Refund / Cancellation policy

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Subject : Performing Effective and Compliant Sterility Failure Investigations


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