Ethylene Oxide (EtO) Sterilization Validation

Ethylene Oxide (EtO) Sterilization Validation

This course provides an overview of the concept of validation with a specific focus on EtO sterilization of medical devices. The course addresses why, what, when, and how to validate from a regulatory perspective, the documentation requirements for 510(k) submissions, and FDA inspection strategies for industry validation programs. Other topics include risk-based approaches to developing a validation program, maintaining a validated state, and generating proper validation documentation.

Audience

Any personnel involved in EtO sterilization such as validation specialists, QA, QC, engineering personnel in the medical device industry, and health care professionals in clinical settings.

Topics Include

  • Regulatory Overview: the concepts of sterility/validation, why, what, when to validate.
  • How to Validate: IQ, OQ, PQ, protocols, critical parameters, FDA inspections, 510(k) submissions requirements.
  • Activity: Design a process validation protocol.
  • Other Topics: when to validate, risk management, validation program, validation documentation, and maintaining a validated state.

Learning Objectives

  • Recognize the concepts of sterility and sterility assurance level (SAL).
  • Identify the advantages and disadvantages of using ethylene oxide.
  • Summarize the regulatory evolution of the validation concept.
  • Define validation from a regulatory and ISO perspective.
  • Summarize the importance of validation, understand when to validate, and determine what needs to be validated based on product impact.
  • Be able to differentiate between verification and validation.
  • Be able to conduct equipment qualification.
  • Identify critical parameters of EtO sterilization validation and draft a protocol.
  • Recognize what documentation is required to set up a validation program.
  • Understand how to maintain a validated state via continuous monitoring.
  • Integrate risk-based management into the validation process.
Ethylene Oxide (EtO) Sterilization Validation

Request this Course

Level: Beginner

Lecture HoursLab or Activity HoursTotal

Delivery Options

Face-to-Face
Delivered in a classroom or lab setting.
Live Instructor Led
Delivered online with a Live Instructor teaching the course at a scheduled date and time.

College Options

Colleges that are able to offer this course.

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