This course provides a comprehensive overview of the cleaning, disinfection, and sterilization validation of medical devices requiring those processes before clinical use to ensure patient safety. Participants will also learn about Instructions for Use that detail cleaning, disinfection, and sterilization processes. Through lectures, case studies, and hands-on exercises, participants will learn the regulatory requirements, industry standards, and best practices associated with validating the cleaning, disinfection, and sterilization processes.

By the end of the course, participants will have gained the knowledge and skills necessary to effectively plan, conduct, and evaluate validation studies for medical devices, contributing to enhanced patient safety and regulatory compliance.

Over the course of twelve (12) hours, the attendee will be able to:

• Classify medical devices according to their requirements for cleaning, disinfection, and/or sterilization, distinguishing between different categories effectively.
• Comprehend and apply regulatory requirements, including US and International standards as well as FDA guidance, ensuring adherence to relevant regulations in device processing.
• Interpret and utilize Instructions for Use (IFU) effectively, ensuring proper handling and processing of medical devices in compliance with manufacturer specifications.
• Conduct risk analysis for medical device reprocessing, identifying potential hazards and implementing appropriate controls to mitigate risks effectively.
• Develop, implement, and validate protocols for cleaning, disinfection, and sterilization of medical devices, including test method validations and documentation of acceptance criteria, ensuring the efficacy and safety of the process.

• Medical Device Manufacturing Professionals with experience in Sterility Assurance, Sterilization and Microbiology.
• Regulatory Professionals with experience in Sterility Assurance, Sterilization and Microbiology.
• Infection Preventionist
• Healthcare Sterile Processing or other clinical professionals that oversee or are involved in the proper reprocessing of medical devices.