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The Most Common Problems in FDA Software Validation & Verification
John E. Lincoln
LIVE : July 09 , 2025 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...

Showing 321-330 of 705 items.
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Patients' Medical Records: Disposition of Records and Records Retention, Including Electronic Record...
Mark Brengleman
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
Mark worked as the assigned counsel to numerous health professions licensure boards as an Assistant Attorney General for the Commonwealth of Kentucky. Moving to private practi...
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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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The Disruptive Practitioner: A Danger to the Hospital's Operation
William Mack Copeland
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

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How to Conduct an Effective Annual Product Quality Review
Danielle DeLucy
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
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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Managing Patients with an Extended Length of Stay
Beverly Cunningham
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Bev Cunningham, MS, RN, ACM is a founding partner of Case Management Concepts, LLC. She has a 25-year deep working knowledge of case management...

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Common Problems and Mistakes in Method Validation in Drug Development Process
Gwendolyn Wise-Blackman
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly ...
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Health Care Investigations by the Government – How They Do It
Mark Brengleman
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
Mark worked as the assigned counsel to numerous health professions licensure boards as an Assistant Attorney General for the Commonwealth of Kentucky. Moving to private practi...
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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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Software FMEA for Medical Devices
Dev Raheja
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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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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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