Workforce Continuing Education Course Catalog

Course
Ethylene Oxide (EtO) Sterilization Validation
Name
SEF-411CL
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
218537 BTEC BioNetwork Capstone Learning Center 02/19/2020 02/19/2020 R. Fernandez $150.00 12/12
Description Course Outline Requirements Intended Audience More Details
Intended 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.
Description
This course provides an overview of the concept of validation with a specific focus on Ethylene Oxide 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.
Course Objectives
  1. Recognize the concepts of sterility and sterility assurance level (SAL).
  2. Identify the advantages and disadvantages of using ethylene oxide.
  3. Summarize the regulatory evolution of the validation concept.
  4. Define validation from a regulatory and ISO perspective.
  5. Summarize the importance of validation, understand when to validate, and determine what needs to be validated based on product impact.
  6. Be able to differentiate between verification and validation.
  7. Be able to conduct equipment qualification.
  8. Identify critical parameters of EtO sterilization validation and draft a protocol.
  9. Recognize what documentation is required to set up a validation program.
  10. Understand how to maintain a validated state via continuous monitoring.
  11. Integrate risk-based management into the validation process.
Outline of Instruction
  1. Regulatory Overview: the concepts of sterility/validation, why, what, when to validate.
  2. How to Validate: IQ,OQ,PQ, protocols, critical parameters, FDA inspections, 510(k) submissions requirements.
  3. Activity: Design a process validation protocol.
  4. Other Topics: when to validate, risk management, validation program, validation documentation, maintaining a validated state.
Contact Hours
8
CEU's
0.8
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
All educational materials will be provided.
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 95% or above
  2. Participation
  3. Acheive 95% on class activities and quiz questions.
Accreditation/Special Approval Requirements
Intended 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.
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
Course Contact Information