Do you use a Contract Sterilizer for your medical device sterilization? Are you not an expert in industrial sterilization? If you answered “yes” to either of these questions, this seminar is a must for you and your team members.

The FDA and your Notified Body will look to you, the medical device manufacturer, for the answers to deficiencies in the sterilization process whether sterilization is performed at your location or at a contract sterilizer.

In this seminar you will be provided a basic understanding of radiation and EO sterilization processes and validation methods associated with both methods. Typical and non-typical sterilization deficiencies will be reviewed and insight provided on the investigation needed to provide root cause to the deficiency and lead to effective CAPA.

CAPA will also be reviewed in detail to provide an understanding of what CAPA is, the regulations and standards involved, and when to apply CAPA. A hands on workshop is held at the end of the sessions where the attendee will be provided “real case” deficiencies and will apply information received during the seminar, ensuring a full understanding of applying CAPA for your sterilization processes.

Day 1

• Introduction to Industrial Sterilization
• Basic terms and definitions
• EO sterilization and Validation processes
• Documenting the EO Validation
• Maintaining EO Validation
• Typical deficiencies in the EO Process and Validation
• Critical and noncritical deficiencies in the EO Process
• Radiation Sterilization and Validation processes
• Determining sterilization dose
• Process validation
• Maintaining validated sterilization dose
• Documenting the Radiation Validation
• Typical deficiencies in the Radiation Process and Validation
• Critical and non critical deficiencies in the Radiation Process
• When you should initiate CAPA with your contract sterilizer

Day 2

• Introduction to CAPA
• Applicable regulations and standards
• Why CAPA
• Defining when to move deficiency to CAPA
• Determining Root Cause
• Determining Actions to Prevent Recurrence
• CAPA tools
• Workshop (1/2 day)
  • utilizing CAPA to solve sterilization deficiencies
  • utilizing CAPA to solve typical quality deficiencies - attendees will present results in workshop

This course benefits anyone involved in ensuring quality for medical devices and is ideal for quality and engineering professionals working in the medical device sector.

• QA personnel
• CAPA team members
• SA personnel
• Quality Engineers
• Operations Managers

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. Most recently she has started her own firm, Adiuvo QS & SA Consulting and has a joint relationship 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.

Ms. Celeste Amlen is an experienced Quality Executive Professional with over 20 years experience in the Medical Device and In-vitro Diagnostics Industries.

A proven Quality Assurance leader with international work experience from several Fortune 500 companies. A successful track record in continuously improving performing Quality Assurance organizations. A catalyst for turning around ailing organizations through the implementation of new organizational structures, system implementations as well as execution of business process transformation projects.

Extensive experience working in a fast paced, high-energy work environment on high visibility projects, with the last eleven years dedicated to Quality Systems and Project Management in the Medical Device and In-vitro Diagnostics industry.

Celeste Amlen has extensive experience interfacing with the FDA in compliance related matters; facility inspections, responding to FDA 483 and Warning Letters, Medical Device Reporting. Setting up quality systems in conformance to ISO13485 and 21 CFRs.