Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
Join us for a webinar on July 01 for a discussion of the webinar
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
Why Should You Attend:
Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology.
Sterilization process parameters will be laid out as a basis for conducting autoclave performance qualification studies. Whether qualifying a new autoclave installation or continuing maintenance of existing equipment, there are specific expectations for steam sterilization that must be met.
Regulatory references requiring use of air removal verification tools, chemical indicators and biological indicators will be provided, along with definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.
Common questions and hot topics in industry will be presented to demonstrate the practical application of understanding steam sterilization. These points exemplify how the knowledge allows for efficient troubleshooting of unexpected events and for improving processes in an autoclave.
Webinar Takeaway
- Definitions.
- IQ/OQ/PQ Requirements for Autoclave Validation
- Autoclave Monitoring Tests
- Biological Indicators - How and When to Use
- Verification vs. Revalidation
Learning Objectives:
- Steam sterilization on a microbial level
- Autoclave Performance Qualification expectations
- Regulatory and GMP requirements for steam sterilization
- Process verification tools for use in an autoclave
- Common questions, problems and cGMPs
Can't Make this LIVE Webinar?
Simply select the Recorded option when registering and we will send you the link to view the recorded version.
Who Will Benefit
- Quality Assurance Managers
- Supervisors
- Validation personnel
- Sterility Assurance personnel
Industries Who Can Attend
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty 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.
