The Basics of Sterilization Processes: Methods, Parameters and Common Cited Deficiencies

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Understand the Critical Parameters for Sterilization Processes, Typical Variable and Recent FDA Cited Deficiencies

Sterilization processes are a critical component in the manufacture of sterile drug products and medical devices. These processes are used to ensure that products are free of microbial contamination and play a crucial role in delivering safe and quality healthcare products for patients. Sterilization of products or components is achieved through a variety of methods.

This webinar by expert speaker Kenneth Christie will review the basic FDA expectations for the most common forms of sterilization. It will review typical variables that need to be controlled for each process and address common deficiencies cited by the FDA for each. The session will weigh the pros and cons for each method and provide common expectations on how to qualify these various methods.

You will get a general oversight as to what each method involves cover and learn about some general sterilization terminologies that are important to be familiar with. In addition, this webinar will cover the common methods of sterilization such as saturated steam, radiation, dry heat, ethylene oxide and the critical parameters for each of the methods. It will 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 without going in to the details of determining sterility assurance levels.

Learning Objective:

  • 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 should attend?

Those who are associated with:

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

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About Our Speaker

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, equipment and utilities,...   More Info
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