Basic Concepts of Sterility Assurance


Instructor: Mark Seybold
Product ID: 705046

  • Duration: 90 Min
This course will provide a foundation for developing your technical skills related to sterility assurance.
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Why Should You Attend:

This presentation will provide an introduction to sterilization science. Sterilization science is rarely included as a significant part any academic course. Therefore, introduction to this science depends on webinars and seminars such this one. It will include the basics of microbiology, microbial inactivation, sterilization theory, bioburden testing, environmental monitoring, sterilization validation strategies, sterility assurance calculations, and description of common sterilization technologies. This course will provide a foundation for developing your technical skills related to sterility assurance.

Learning Objectives:

  • Understand the science and math of microbial inactivation and sterility assurance
  • Understand how to develop a sterilization program
  • Understand how to select the type of sterilization process most appropriate for your product
  • Understand how to validate a sterilization process
  • Understand how manage sterilization during routine production

Areas Covered in the Webinar:

  • History of Sterilization
  • Basic Microbiology
  • Microbial Growth
  • Bioburden Monitoring and Control
  • Microbiological Inactivation
  • Biological Indicators
  • Sterilization Validation Strategies
  • IQ/OQ/PQ
  • Sterility Test
  • Common Sterilization Processes (Moist Heat, Ethylene Oxide, Radiation)
  • Routine Sterilization Processing

Who Will Benefit:

  • Microbiologists
  • Engineers
  • Quality Personnel
  • R&D specialists
Instructor Profile:
Mark Seybold

Mark Seybold
Pharmaceutical Consultant, Mark Seybold and Associates

Mark A. Seybold has 32 years of experience in the field of sterilization. He is currently the President of Seybold & Associates consulting, with a focus on pharmaceutical and medical device companies. He was employed at Baxter Healthcare for 30 years and held the position of Sr. Manager of Sterility Assurance. His areas of expertise include radiation, ethylene oxide, and moist heat sterilization. He has served as a member of various sterilization working groups in the Association for the Advancement of Medical Instrumentation (AAMI) and has contributed to the development of standards in the areas of radiation sterilization, ethylene oxide sterilization, and microbiological methods. He has authored a chapter on radiation sterilization in 2 different publications. Mr. Seybold has B.S. in Microbiology and an MBA from Indiana University. He has served as an instructor for the “Microbiology and Engineering of Sterilization Processes” course offered by Dr. Irving J. Pflug.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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