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Validity : 21st Apr'24 to 01st May'24
The Basics of Sterilization Processes; From Typical Parameters to Problems
- Review the common terminology associated with the various sterilization methods
- Review the most common methods of sterilization (steam, ETO, dry heat, filtration, gamma)
- Discuss the critical parameters monitored for each sterilization method
- Review common deficiencies cited with each method reviewed
Overview of the webinar
The sterilization of products or components is achieved through a variety of methods. This webinar will cover the common methods of sterilization such as saturated steam, radiation, dry heat, ethylene oxide, the terminology and the critical parameters associated with each. In addition, this webinar will also highlight recent deficiencies cited by the FDA regarding sterilization methods and their validation. This is a good basic course for those getting involved with performing and understanding sterilization cycles but will not get into details with regards to determining sterility assurance levels.
Who should attend?
This webinar will provide valuable assistance to all personnel in:
- QA/QC
- Manufacturing
- Engineering
- Validation
- Regulatory
- Management
- Production
- Laboratory
Why should you attend?
This webinar will review the basic expectations for the most common forms of sterilization. The typical variables that need to be controlled for each will be reviewed along with the common deficiencies cited for each. Pros and cons for each method will be highlighted along with common expectations for how to qualify these various methods. This webinar provides a general oversight as to what each method involves but does not get into the specifics for determining sterility assurance levels. It will cover some general sterilization terminology that the attendees should be familiar with.
Faculty - Mr.Kenneth Christie
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc., located in Amherst, MA. His responsibilities specifically include quality system auditing, GMP training and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities and systems on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.
Mr. Christie was the validation manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products. Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.