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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 491-500 of 705 items.
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Risk Management - Principles of Lean Documents and Lean Configuration
Jose Mora
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
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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Best Practices in Preparation for an FDA Computer System Audit
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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Reliability Engineering Fundamentals 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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USP <71> Sterility: New Updates and Harmonization
Erika L. Roberts, M.F.S
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Erika L. Roberts, M.F.S, is a Masters in Forensic Science (with an emphasis in document examination) and currently works as a Senior Quality Assurance Analyst and as a freelan...
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Regulatory Inspections – How to Prepare for a Visit from an FDA Auditor
Denise Wrestler, ASQ CQE, CQA
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

With over 15 years of experience

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Introduction to Root Cause Investigation for CAPA
Vanessa Lopez
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Vanessa Lopez is senior principle quality,  regulatory and compliance consultant. She has held a wide variety of leadership roles in the m...

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Understanding Recent Advancements and Paradigms in Immunology
Matthew M. Seavey, PhD, MBA
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Matthew M. Seavey, PhD, MBA – Founder & President of BioPoint Consulting, LLC, holds over a decade of drug development experience. Or...

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Allergen Cleaning, Validation and Preventative Risk Mitigation for FSMA
Gina M. Reo
Recorded Duration : 60 Minutes
Life Sciences > Food Safety And Dietary Supplements

President, QAS, (Quality Assurance Strategies, LLC), private consultation for the Food and Beverage Industry specializing in Global Food Safety...

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How to Make Design Part of Your Product Development DNA
Tom Kramer
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Tom Kramer, president and CEO of Kablooe Design, has been a product innovator for over 26

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What is New for HIPAA in 2018
Jim Wener
Recorded Duration : 60 Minutes
Life Sciences > Healthcare

Jim Wener has over 40 years of experience in assisting health care organizations - both providers and payers - in identifying their automation ...

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