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Showing 1-3 of 3 items.
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Essentials of Validation – IQ, OQ, PQ
LIVE : October 15 , 2025 01:00 PM EDT
Life Sciences > Medical Devices
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Good Documentation Guideline (Chapter <1029> USP)
Dr. Afsaneh Motamed Khorasani
LIVE : October 16 , 2025 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | Laboratory

Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical sc...

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How to Prepare For and Host a FDA Inspection and Respond to 483’s
Edwin Waldbusser
LIVE : October 16 , 2025 01:00 PM EDT
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 703 items.
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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Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Sy...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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Good Documentation Practices to Support FDA Computer System Validation
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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Software Development for Medical Device Applications Under IEC 62304
Don Hurd
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Don Hurd has over 35 years of experience in supporting development of applications both in the commercial space and in regulated industries, in...

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