Application of CAPA in (Device) Sterilization - For the Non-Expert

Instructor: Lisa Foster
Product ID: 702187
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This webinar will review the typical non-conformances experienced in the (Medical Device) sterilization process and the course of action that should be taken by the manufacturer or contract sterilizer.

Course "Application of CAPA in (Device) Sterilization - For the Non-Expert" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

Most device manufacturers utilize a contract sterilizer for terminal sterilization of their products, e.g., radiation and EO. Non-conformances can occur during the sterilization process and CAPA needs to be issued by the manufacturer or contract sterilizer. For those that are not sterilization experts, a basic knowledge needs to be obtained to determine that the CAPA root cause, action to prevent recurrence, and verification/validation of the CAPA has been performed.

As the world and meaning of CAPA evolves in the device manufacturing environment, further misunderstanding comes about when determining root cause and corrective action for this critical step in the device manufacturing process.

This presentation will help you better understand the sterilization process and how the manufacturer can manage CAPA as it relates to the sterilization process. This webinar will review typical non-conformances experienced in the sterilization process and the course of action that should be taken by the sterilization processor.

Learning Objectives:

  • Introduction to basics of EO and Radiation critical control points.
  • What can go wrong?
  • Which deficiencies are critical?
  • Options for corrective action at the sterilizer.

Areas Covered in the Seminar:

  • Basic critical control points of EO and Radiation Sterilization.
  • Review of typical nonconformities.
  • Review of actions that should be taken by the sterilization processor.
  • What should you expect from your contract sterilizer as it relates to CAPA issued by sterilizer or you the manufacturer.

Who Will Benefit:

This webinar is for people involved in project management, design and production activities for medical device manufacturing.

People in the following roles can especially benefit from the knowledge in this webinar:
  • QA personnel
  • CAPA team members
  • SA personnel
  • Quality Engineers
  • Operations Managers

Instructor Profile:

Ms. Foster, began her medical device career at Sterigenics International in 1989. Throughout her tenure, Ms. Foster has held various quality assurance positions at both the facility and Corporate levels where she served as Sterigenics Vice President of Quality Assurance from 1997 – 2004 and as Vice President SteriPro Labs & Consulting from 2004-2011. In 2011 she opened her own firm Adiuvo QS & SA Consulting and formed an alliance with Blue Skies, LLC.

Ms. Foster is an Executive Committee Member of the AAMI Sterilization Standards Board (invitation only), a member of the AAMI Sterilization Standards Committee (invitation only), serves as Co-Chair and ISO delegate to AAMI/ISO/TC 198/WG2 Radiation Sterilization Working Group, has served as co-chair for the AAMI Radiation Process Control Task Group, which developed TIR 29, Guide for Process Control in Radiation Sterilization, and is also an active member of several other AAMI Sterilization Working groups. Ms. Foster has been a presenter at numerous industry and FDA training seminars throughout the United States. She holds a Bachelor of Science in Food and Nutrition from Mississippi University for Women and a Masters of Science in Food Technology from Mississippi State University. Ms. Foster's areas of expertise include sterilization, sterilization validation, regulatory compliance, Quality System Regulation, quality systems management, CAPA, and FEMA.

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