EO STERILIZATION VALIDATION
ABOUT THE TRAINING
This expert-led virtual training is designed to provide medical device professionals with practical knowledge of EO sterilization validation, qualification approaches, process control, regulatory expectations, and industry best practices. The program focuses on applying validation principles to demonstrate sterilization effectiveness and achieve the required Sterilization Assurance Level.
KEY TOPICS COVERED
• EO Sterilization Validation
• Microbiological & Physical Performance Qualification
• EO Residuals & Process Control
• Regulatory Expectations & Best Practices
• Case Studies & Real-World Examples
WHO SHOULD ATTEND?
QA/RA Professionals, Validation Specialists, Microbiologists, Packaging Engineers, and Medical Device Professionals.
TRAINING HIGHLIGHTS
• Industry-Focused: Relevant and practical insights.
• Expert-Led: Learn from experienced sterilization professionals.
• Regulatory Aligned: Stay updated with global regulatory expectations.
ABOUT THE TRAINER
Vincent Lam is an independent expert in medical device sterilization with 35 years of experience conducting validations and qualifications to verify the effectiveness of sterilization processes in achieving the required Sterilization Assurance Level and supporting the realization of safe medical devices.
His experience includes serving as a Technology Assessor and Product Specialist for a Notified Body, where he developed assessment modules for evaluating sterilization validation outcomes. These assessments supported certification activities under regulatory schemes such as the EU MDR and MDSAP.
He has conducted public training courses intended to help industry participants understand and apply current sterilization standards, including ISO 11135, ISO 17665, ISO 11137, and ISO 20857.
REGISTRATION Registration Form: https://forms.gle/1UabZ5N6vDkk6TbG7
