Dental Laboratories - 3D Printing of PPE, an FDA Compliance Panel Discussion
This webinar will cover key issues related to dental laboratories who are trying to help the country in a time of need with COVID-19 by 3D printing PPE for the health care supply chain. Depending on the type of device, there are different U.S. FDA requirements and compliance for manufacturers of PPE. Some PPE is Class I and some is Class II. For dental laboratories that are not already registered with FDA printing some PPE may require FDA registration. There may also be additional quality system measures that come with printing PPE in mass quantity as well as labeling requirements depending on the distribution channels being used. The FDA provides some guidance at https://www.fda.gov/medical-devices/3d-printing-medical-devices/faqs-3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic .
Upon purchase, you will have 30 days of access to the course.
Requirements for Course Completion
Participants will view the one-hour video and complete a short test. Participants must correctly answer at least 80% of the test questions to receive credit. If a grade of at least 80% is not achieved, the test may be repeated two times.
Accreditation
Upon successful completion of this course, participants will receive one hour of Regulatory Standards through the National Board for Certification in Dental Laboratory Technology (NBC).
Credit Information
Activity Number
Credit Amount
Accreditation Period
39952
1 Regulatory Standards
from April 09, 2020
Instructors
Eric Thorn
Instructor
Eric Thorn serves as in-house counsel for the National Association of Dental Laboratories (NADL). He is a leading voice for American dental laboratories on regulatory topics and works with state dental laboratory associations across the country helping to develop, present, and advance proposals and legislation relating to basic standards for the dental laboratory technology profession nationwide.
Eric Thorn formerly served as the General Counsel of the Florida House of Representatives. Prior to joining NADL, he spent over a decade in private practice with a prestigious Florida-based law firm representing businesses and associations in governmental relations and business development matters.
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Gary Morgan
Instructor
Gary Morgan, CDT, ASQ CQA is Vice President and a Compliance Advisor of SafeLink Consulting. After completion of studies in History and Government at the University of Texas at Austin, Gary worked for three years in retail business management and human resources.
In 1977 Gary joined Morgan Dental Laboratory, which his wife founded in 1975. Gary became a Certified Dental Technician in 1991. Active in the Dental Laboratory Association of Texas, Gary served as Legal and Governmental Affairs Chairman for DLAT 1987-2007, representing members before governmental agencies, the State Board of Dental Examiners, and the Texas Legislature.
Gary began lecturing on safety and infection control in 1989 and is an Authorized Trainer under OSHA’s Outreach Program. Gary is an ASQ-Certified Quality Auditor, an authorized DAMAS consultant and DAMAS certification auditor and presenter at workshops and tradeshows on the topic of quality systems and health and safety.
In 2008, Gary was awarded the Merit Award in Recognition of Contributions and Outstanding Service to the Dental Laboratory Profession by the National Association of Dental Laboratories. In 2009, he was honored with the Dental Laboratory Association of Texas Hall of Fame Award.
From 2008 to 2010, Gary served as Chairman of the Dental Laboratory Certification Council.
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Mary Borg-Bartlett
Instructor
Mary Borg-Bartlett is President and Co-founder of SafeLink Inc., a leader in the dental industry for occupational safety and health and human resource management services. Since 1991, Mary has actively participated as a presenter and on-site instructor to audiences of dentists, dental hygienists, dental assistants, and dental laboratory technicians throughout the country. Her career in the corporate world in Risk Management, Crisis and Disaster Recovery, and Human Resource Management has provided her tremendous insight into governmental requirements. Ms. Borg-Bartlett’s extensive 20 year background in Human Resource Management includes Director of Human Resources for a national family entertainment company with amusement parks located throughout the U.S. where safety was not only an employee concern, but also a customer safety issue.
She is an active member of the Society for Human Resource Management (SHRM) in Atlanta, currently servicing the 2500 member chapter as Vice President of Finance. Mary also serves on the Executive Board of the Northwest Georgia Chapter of the March of Dimes. Her formal education was gained at Bauder College in Atlanta and Georgia State University. Mary is an authorized trainer under OSHA’s Outreach Program.
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