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Showing 11-13 of 13 items.
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Verification and Validation – Product, Process or Equipment and QMS Software
John E. Lincoln
LIVE : November 22 , 2024 01:00 PM EST
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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Problem Solving - Root Cause Analysis in Pharma Manufacturing
Joy L. McElroy
LIVE : November 26 , 2024 01:00 PM EST
Life Sciences > Pharmaceutical

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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Essentials of Validation – IQ, OQ, PQ
LIVE : November 27 , 2024 01:00 PM EST
Life Sciences > Medical Devices
Showing 521-530 of 691 items.
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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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Special Considerations during Medical Device Design - Dos and Don'ts
Dev Raheja
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Effective Records Management & Document Control for Medical Devices
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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The Use and Misuse Of FMEA In Medical Device Risk Management
Dev Raheja
Recorded Duration : 75 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Dimensional Analysis for Scientific Scale-Up
Michael Levin
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Michael Levin, Ph.D., has edited a very popular “Pharmaceutical Process Scale-Up” handbook (3rd edition published in 2011), and has contributed chapters on “Tablet Press...
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