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Showing 1-4 of 4 items.
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Human Factors-Usability Based on ISO 62366
John E. Lincoln
LIVE : April 26 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated ind...

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Understanding the Five Pillars of 5S for Operators
Dr. Ginette Collazo
LIVE : April 29 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines ...
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Medical Device - Engineering Change Control
Edwin Waldbusser
LIVE : May 02 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development ...
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Technical Writing in an Industrial Environment
Robert Peoples
LIVE : May 03 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

After obtaining a B.S. and an M.S. in Chemistry from Tuskegee University, Robert Peoples joined the pharmaceutical industry as a Research Chemi...

Showing 91-100 of 178 items.
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Medical Device Risk Management Following ISO 14971:2019
Edwin Waldbusser
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development ...
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Software Cybersecurity – Prevention and Recovery
Casper (Cap) Uldriks
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device prog...
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Effective SOP Development for Regulatory Compliance
Danielle DeLucy
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in o...
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Documentation Successful 510 (k) Documentation for Software or Software Containing Medical Devices
Nancy Knettell
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulato...

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3-hr Virtual Seminar: The Medical Device Trials in the EU: A Guide to the New EU MDR and Revised ISO...
Dr. Frank Stein
Recorded Duration : 180 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac su...

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Design Reviews and Design Controls to meet FDA Requirements
Dev Raheja
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies ev...
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Understanding Medical Device Software / IEC 62304 Compliance
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated indust...
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3 Hours Virtual Seminar: Understanding and Controlling Biofilm - Preventing Water System Microbial P...
T C Soli
Recorded Duration : 180 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer produc...
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Corrective and Preventive Action & Quality Managemet System
William A. Levinson
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

William Levinson is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Qual...

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Quality by Design - Essential Techniques for Medical Devices
Susanne Manz
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background ...
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