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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...

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Food Importation and FDA Oversight
Joe Lynch
Recorded Duration : 75 Minutes
Life Sciences > Food Safety And Dietary Supplements

Joe Lynch is the founder of The Logistics of Logistics, a logistics training and consulting firm. Joe specializes in helping logistics and tran...

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Good Laboratory Practices (GLPS) Comparing and Contrasting With Good Manufacturing Practices (GMPS)
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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Validation Of Preventive Controls-Prepare Your Company to Meet The Final FSMA Rule Requirements for ...
John Ryan
Recorded Duration : 60 Minutes
Life Sciences > Food Safety And Dietary Supplements

Dr. John Ryan is the president of RyanSystems.com and holds a Ph.D. in research and statistical methods.  For more than 25 years, he has i...

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The Importance of Protocol Deviations and Violations to Subject Safety and Data Integrity will Surpr...
Dr. Charles H Pierce
Recorded Duration : 90 Minutes
Life Sciences > Clinical Trial

Charles H Pierce is Medical Director of Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) throug...

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Validation Of Pharmaceutical Compressed Gasses
Igor Gorsky
Recorded Duration : 75 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Igor Gorsky, Sr. Consultant, ConcordiaValsource, LLC. He has over 30 years of experience leading validation, technology transfer, quality assurance and manufacturing functions...
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Reprocessing Reusable Medical Devices Cleaning & Labeling Requirements
John Chapman
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC....
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How to Get That 510(K) Out Of The Way
Jim Dunning
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Jim’s consulting career began in 2001 and has consulted in quality and regulatory for companies ranging from Fortune 500 medical device companies to start-up medical device ...
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Transitioning Assays From Different Technologies: Validation and Qualification
Todd Graham
Recorded Duration : 60 Minutes
Life Sciences > Biotechnology
Todd Graham , is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. He has work for ...
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Validation Of Cell Based Assays
Recorded Duration : 60 Minutes
Life Sciences > Biotechnology
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How to Break Into Brazilian Market - A Regulatory Overview for Cosmetics and Personal Hygiene Produc...
Claudia De Lucca Mano
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

With a law office in Sao Paulo, Brazil, since 1994, Claudia Thereza de Lucca Mano is a practicing attorney and consultant, who specializes on B...

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