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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 631-640 of 705 items.
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Trial Master File (TMF): Meeting FDA Expectations
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Clinical Trial
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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Trial Master File (TMF): Meeting FDA Expectations
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Clinical Trial
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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How to Prepare for and Host a FDA Inspection and Avoid 483’s (based on practical experience)
Edwin Waldbusser
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
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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3-hr Virtual Seminar: Understanding Requirements of a Bioanalytical Method Validation
Gwendolyn Wise-Blackman
Recorded Duration : 180 Minutes
Life Sciences > 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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3-hr Virtual Seminar: Equipment Qualification and Validation of Processes in the Manufacturing Envir...
Joy L. McElroy
Recorded Duration : 180 Minutes
Life Sciences > Pharmaceutical

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. ...

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21 CFR Part 11-Electronic Records, Signatures - Compliance for Computer Systems Regulated by FDA
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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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Understanding and Implementing a Quality by Design Program
Steven Laurenz
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled i...
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Vendor Qualification - Evaluating Vendors & Understanding their Capabilities
Todd Graham
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Todd Graham , is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. He has work for ...
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Complying with ISO-IEC 17025 Requirements for Effective Laboratory Quality Management System
Michael Brodsky
Recorded Duration : 90 Minutes
Life Sciences > Laboratory

Michael has a post-graduate degree from the University of Toronto, School of Hygiene and Tropical Medicine and been an Environmental Microbiolo...

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Understanding Combination Products: Navigating the Rules and Regulations
Charles H. Paul
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant...
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