Live Webinar Designing An Effective Cleaning Validation For Reusable Medical Devices In Today's Regulatory Environment

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Hear By Dr. David Lim, Ph.D., RAC, ASQ-CQA. Recently, He developed 510(k) templates ready for use compliant with e-Copy and RTA policy."

FDA expectations regarding reusable medical device design considerations

Description

In recent years, there have been many reported incidents of patient infection as a result of reusable medical devices that have been inadequately cleaned and reprocessed.  Firms are subject to quality system regulation even if some cleaning devices of reprocessing reusable medical devices may be exempt from 510(k) premarket notification requirements. 

This seminar is intended to discuss FDA expectations regarding reusable medical device design considerations, cleaning validation methods and labeling instructions for reprocessing reusable medical devices in compliant with FDA’s current policy.  

In particular, the speaker will present what the firms should consider when developing cleaning validations including cleaning instructions for reprocessing reusable medical devices. 

In this conference, the speaker will guide you through FDA’s current policy and regulatory requirements on cleaning validation for reprocessing reusable medical devices

Areas Covered

•     Laws and Regulations
•     FDA Guidance and Definitions
•     Important Design Considerations for Reusable Medical Devices
•     Developing Reprocessing Instruction and Considerations
•     Human Factors to Consider
•     Criteria for Consideration When Developing Cleaning and Reprocessing Instructions
•     FDA Cleared Cleaning Instruments
•     Documentation Requirements for Premarket Notification 510(k) or PMA
•     Summary of Recent Incidents Including Death
•     Common Pitfalls and How to Avoid
•     Enforcement Actions: Case Studies
•     PASS-IT Recommendations: Best Practices

Who will Benefit

•     R&D Scientists, Engineers, Managers, and Directors
•     Regulatory Affairs
•     Quality Professionals
•     Product Development and Design Professionals
•     CROs
•     Consultants
•     Senior Management
•     Contractors and Subcontractors
•     Anyone Interested in the Subject

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Dr. David Lim Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us).  As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. 

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

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