Sterilization Processes – The Methods, Parameters and Deficiencies

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 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.

Areas Covered in the Session :

  • 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
Who Will Benefit:

  • Quality Assurance Teams
  • Quality Control Teams
  • Manufacturing Teams
  • Production Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory Teams
  • Laboratory Personnel
  • Management
  • Equipment vendors

FDB2366

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. Specifically, his responsibilities 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. Mr. Christie 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, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.