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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 161-170 of 703 items.
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Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
Gwendolyn Wise-Blackman
Recorded Duration : 90 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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Technical Writing in the Pharmaceutical Industry
Robert Peoples
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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

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PMA’s, IDE’s, and De Novo Submissions
John E. Lincoln
Recorded Duration : 90 Minutes
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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Health Care Compliance: Conducting Risk Assessments
Danielle Watts
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Danielle Watts, hailing from Savannah, Georgia, was raised with a strong educational background. She holds a Bachelor of Science in Sociology, ...

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Navigating Privacy and Security in 2023: More than Out-of-the Box Basics
Michi McClure
Recorded Duration : 75 Minutes
Life Sciences > Healthcare

A. Michi McClure, J.D. seeks balance in everything she does, and she attributes that balance as one of the primary reasons for her success as a...

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Understanding Closed-Loop CAPA System
John E. Lincoln
Recorded Duration : 90 Minutes
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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Compliance with Good Clinical Practice (GCP)
John E. Lincoln
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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CPRA, HIPAA & GDPR: Data Privacy Laws Affecting Businesses in 2023 - How to Comply?
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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Best Practices and Common Pitfalls Related to FDA Compliance for Computer System Validation (CSV)
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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U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process
John E. Lincoln
Recorded Duration : 90 Minutes
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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