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How to Prepare For and Host a FDA Inspection and Respond to 483’s
Edwin Waldbusser
LIVE : March 19 , 2026 01:00 PM EST
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 ...
Showing 191-200 of 705 items.
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Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals and Biologics
Gwendolyn Wise-Blackman
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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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Advanced Auditing Strategies for Data Integrity Risks
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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Analytical Method Validation Under Good Laboratory Practices (GLPs)
John C. Fetzer
Recorded Duration : 60 Minutes
Life Sciences > Laboratory
John C. Fetzer, has had over 30 year experience in GC and GC-MS methods development. He has authored or co-authored over 50 peer-reviewed papers on chromatography, has served ...
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The Nuts and Bolts of Filing a Whistleblower Case
William Mack Copeland
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

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Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Sy...
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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HIPAA Compliance Monitoring and Auditing
Marina Malikova
Recorded Duration : 90 Minutes
Life Sciences > Healthcare | Clinical | Laboratory

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investiga...

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FDA Regulation of Artificial Intelligence & Machine Learning
Jose Mora
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences ind...
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FDA Regulations for Analytical Instrument Qualification and Validation Processes
Joy L. McElroy
Recorded Duration : 75 Minutes
Life Sciences > Device| Pharma| Lab|Clinical

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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Cybersecurity – FDA Requirements Masterclass
John E. Lincoln
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

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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Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance
John E. Lincoln
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

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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