Designing An Effective Cleaning Validation For Reusable Medical Devices In Today

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

Effective Cleaning Validation For Reusable Medical Devices

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:

  • Laws and regulations
  • Cleaning methods
  • Cleaning process: requirements
  • Process validation
  • Cleaning testing requirements
  • Test types and test protocols
  • Labeling requirements
  • Removal or inactivation of Transmissible Spongiform Encephalopathy (TSE) agents (Prions)
  • Ineffective, partially-effective, effective disinfectants or sterilants
  • Common mistakes in SOPs and during actual practices
  • How to reduce and prevent common mistakes
  • Liability cases
  • FDA enforcement cases
  • Speaker’s PASS-IT suggestions/recommendations
  • Conclusion

Who should attend:

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • R&D
  • Consultants
  • Contractors/subcontractors
  • Anyone interested in the US FDA’s strategic priorities

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( 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.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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