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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 521-530 of 705 items.
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Advanced Course on Lean Documents, Lean Configuration and Document Control
Jose Mora
Recorded Duration : 90 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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Quality Metrics and Risk Based Inspections: Quality Metrics Guidance for Industry & Safety and Innov...
Angela K. Dunston
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics)...
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Writing Effective SOPs for FDA and CLIA Regulated Companies
Angela Bazigos
Recorded Duration : 90 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roc...
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Raw Materials Risk Management In GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Iss...
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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Hazard Analysis Following ISO 14971
Edwin Waldbusser
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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FDA's Quality Metrics Program and Scorecards: Critical Success Parameters
Joy L. McElroy
Recorded Duration : 75 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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QSR and ISO Requirements for Supplier Evaluation and Assessment
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operat...
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How to Conduct A HIPAA Risk Assessment and Write Policies
Recorded Duration : 90 Minutes
Life Sciences > Healthcare
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The DOJ Gets Personal: 6 Things You Should Know About the Yates Memo
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
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Ensuring Compliance Of Your Bioanalytical Method Validation With The 2013 FDA Draft Guidance
Brian Kirk
Recorded Duration : 75 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory
Brian A. Kirk, Ph.D. has been employed in both the biotech and pharmaceutical industries for over 20 years. He has a wealth of experience, working in the areas of synthetic or...
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