Course Description:

Sterilization is a critical aspect of device approval and release. Though this is indeed fact, manufacturers sterilize product as a matter of course, without expert sterilization assurance personnel to guide them through potential problems in sterilization. As the world and meaning of CAPA continue to evolve in the medical device industry, further misunderstanding arises when faced with determine root cause and corrective (or preventive) action for any variation in this critical process in device manufacture.

The course will begin with an overview of EO sterilization, explaining which aspects of the process often cause confusion. This will be followed by process validation and what paperwork is required to provide ‘documented evidence’ ; and finally what are typical deficiencies encountered in the EO process. Next a detailed explanation of Radiation Sterilization will be given. Specific to Radiation Sterilization is the required sterilization dose, which will be covered in depth – how to determine sterilization dose and how to maintain the validated dose. Process validation will be covered as well as the typical deficiencies encountered in Radiation Sterilization and Validation. Critical and non-critical deficiencies will be covered and when this should trigger a CAPA. Finally contract sterilization will be reviewed with the specifics of how to deal with CAPA when you are not directly responsible for sterilization.

Who will Benefit:

This course will be beneficial to the following personnel in Medical Device Manufacturing and Sterilization facilities:

  • QA Personnel
  • CAPA Team Members
  • SA Personnel
  • Quality Engineers
  • Operations Managers
  • Anyone with direct hands on experience with sterilization & troubleshooting

Course Outline:

Day 1


Day 2

  • Introduction to Industrial Sterilization
    • EO sterilization and Validation
      • Documentation & Maintaining Validation
      • Typical Deficiencies: Critical and Non-critical
    • Radiation Sterilization & Validation
      • Determining and Maintaining Accurate Dose
      • Process Validation & Documentation
      • Typical Deficiencies: Critical and Non-critical
    • Contract Sterilization
  • Introduction to Corrective & Preventive Action - CAPA( ½ Day)
    • Applicable Regulation & Standards
    • Why CAPA
    • When does a deficiency require CAPA?
    • Root Cause Determination
    • Actions to Prevent Recurrence
    • CAPA Tools & Methodology
  • Workshop (½ Day)
    • Utilizing CAPA tools to solve sterilization deficiencies
    • Utilizing CAPA tools to solve typical quality deficiencies
    • Instructors will lead attendees through several ‘real case’ exercises related to CAPA and sterilization & quality deficiencies; attendees will present findings to the rest of the group.

Meet Your Instructors

Lisa Foster
Principal , Adiuvo QS & SA Consulting

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 Karen Welch, Senior Partner of Center for Risk Based Strategies (CRC). 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.

Karen Welch
Senior Partner, Center for Risk-based Strategies (CRS)

Ms. Welch is a Senior Partner with Center for Risk-based Strategies (CRS), a company focused on improving the bottom line of regulated companies. She has over 20 years of experience in the Medical Device, Pharmaceutical and Diagnostics industry with a primary focus in Quality Improvement and Quality Systems. She held positions of increasing responsibility, both technical and managerial, at Abbott Laboratories, Sybron International, AbTox, and Aksys, Ltd. Throughout each of these positions she actively practiced Continuous Improvement and Six Sigma techniques to help design quality into the product as opposed to ‘checking it in’ at the end. Ms. Welch was in charge of Quality Assurance and Quality systems relating to all aspects of the manufacture and release of FDA regulated products. She assisted in creating and maintaining ISO and QSR compliant organizations. She managed Complaint Handling, Investigation and root Cause analysis using statistically valid data summaries, insuring that corrective and/or preventive actions were incorporated to avoid recurrence. She identified and tracked key metrics to measure Cost of Poor Quality, i.e. defect rates, yield, variation, cycle time, product/process development time, and waste. Most recently Ms. Welch was Director of Six Sigma of a major medical firm where she played a key role in teaching Lean and Six Sigma tools and techniques to challenge current ways of working and gain improvements in cycle time, productivity and delivery performance in Southeast Asia, Australia, London and America. She has extensive experience with DOE and has used it to characterize, optimize and validate products and processes. Ms. Welch received her B.S. in Medical Technology at Chicago Medical School, University of Health Sciences, North Chicago, Illinois. She is a Senior member of American Society for Quality.

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