Steam Sterilization Microbiology and Autoclave Performance Qualification
Product Id : FDA203Instructor : Danielle DeLucy
Mar 12, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes
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Description
Analyze the steam sterilization mechanism as it relates to endospores and bacterial cells
Fundamental understanding of steam sterilization microbiology is essential for successful autoclave performance qualification. The webinar will lay out parameters of the sterilization process on a basis for conducting autoclave performance qualification studies. There are specific expectations for steam sterilization that must be met, whether it is continuing maintenance of existing equipment or qualifying a new autoclave installation. The session will also provide regulatory references on use of air removal verification tools, chemical indicators and biological, along with definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.
In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. She will define key terminologies and processes and provide an understanding of fundamentals crucial in creating a successful autoclave sterilization process.
Danielle will discuss the practical application of steam steam sterilization, address common questions, and cover industry hot topics. This knowledge will help professionals in efficient troubleshooting of unexpected events and for improving processes in an autoclave.
Session Highlights:
- Steam sterilization on a microbial level
- Autoclave Performance Qualification expectations
- IQ/OQ/PQ Requirements for Autoclave Validation
- Autoclave Monitoring Tests
- Biological Indicators – How and When to Use
- Regulatory and GMP requirements for steam sterilization
- Process verification tools for use in an autoclave
- Common questions, problems and cGMPs
- Verification vs. Revalidation
Who Should Attend?
- Quality Assurance Professionals
- Supervisors
- Validation personnel
- Sterility Assurance personnel
Speaker Profile:
Danielle DeLucy,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 their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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