This session is intended to discuss points of consideration and requirements to develop an effective cleaning method validation for reusable medical devices.
In recent years, there has been a significant advance and complexity in medical device design and technology. Due to complex reusable medical devices, it becomes more difficult to clean and disinfect or sterilize medical devices.
To adequately meet FDA labeling regulations, a firm must provide adequate directions for use including instructions on preparing a device for usage. Instructions on how to reprocess (i.e., clean) a reusable device are of paramount importance to ensuring a reusable device is appropriately prepared for its next use.
This webinar by Dr. David Lim, Ph.D., RAC, ASQ-CQA, will provide you an opportunity to understand and apply key elements of process validation for cleaning medical devices, so that devices can be adequately cleaned for the next step. In addition, this webinar will discuss how to remove or inactivate prions including what are ineffective, partially-effective and effective disinfectants or sterilants.
In this presentation, the speaker will share his Practical, Actionable, Sustainable Solutions/Strategies in an Integrated, Thorough (“PASS-IT”) manner.
Areas To Be Covered in this Webinar:
Who should attend:
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.