Live Webinar Current FDA Laws and Regulations on Radiation-Emitting Products and Radiation-Emitting Electronic Products

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins 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."

Current FDA Radiation Control Laws

Description

This webinar is intended to discuss current FDA laws and regulations governing medical devices known as electronic products including radiation-emitting products (collectively called as “electronic products”). 

In the US, electronic products are subject to statutory and regulatory requirements under the applicable statute and regulations. There are various examples of electronic products: either medical or non-medical purposes.

This presentation is intended to discuss electronic products used for medical purposes.  To bring various electronic products into the US market for use in medical purposes, it is imperative industry should be well familiar with the statutory and regulatory requirements applicable to the electronic products for medical purposes. The electronic products used for medical purposes include, but are not limited to, microwave or ultrasound diathermy devices , x-ray (diagnostic), ultrasound imaging devices, microwave blood warmers, laser coagulators, X-ray or electron accelerators, sunlamps, ultraviolet dental curing devices, etc.

This presentation will provide great opportunities to improve awareness and to get better familiar with the statutory and regulatory requirements to obtain FDA clearance or approval for electronic products. 

This conference will provide great opportunities to learn about the laws and regulations governing radiation-emitting products and radiation-emitting electronic products in the US.  

Areas Covered

•      Radiation Control Laws 
•      Definitions
•      Regulations for Radiation-Emitting (Electronic) Products
•      Common Misconception about Laws, Regulations, and FDA Guidances
•      Regulatory Requirements for Radiation-Emitting (Electronic) Products
•      Radiation Safety
•      Common Problems for Recalls of (Radiation-Emitting) Electronic Products
•      FDA Program for Electronic Product Radiation Control
•      FDA-Cleared Radiation-Emitting Electronic Products
•      Best Practices

Who will Benefit

•     Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
•     Regulatory Affairs
•     Clinical Affairs
•     Quality Assurance
•     Compliance Officers
•     Radiation Safety Officers
•     Laboratory Personnel
•     R&D
•     Consultants
•     Contractors/Subcontractors
•     Other professionals interested in this topic

Industries who can attend

This 90-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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