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Showing 1-3 of 3 items.
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Risk Assessment in Medical Device Design
Charles H. Paul
LIVE : January 08 , 2025 01:00 PM EST
Life Sciences > Medical Devices
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant...
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FDA Audit Best Practices - Dos and Don'ts
Charles H. Paul
LIVE : January 24 , 2025 01:00 PM EST
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant...
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Validation of Complex Cell-Based Potency Methods
Gwendolyn Wise-Blackman
LIVE : January 31 , 2025 01:00 PM EST
Life Sciences > Clinical Trial
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 ...
Showing 21-30 of 702 items.
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How to Write SOP’s for Human Error Reduction
Dr. Ginette Collazo
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines ...
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Trial Master File (TMF): Meeting FDA Expectations
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Clinical Trial
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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3-hr Virtual Seminar: Equipment Qualification and Validation of Processes in the Manufacturing Envir...
Joy L. McElroy
Recorded Duration : 180 Minutes
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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Medical Device - Engineering Change Control
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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How to Prepare a Standard Operating Procedure
Dr. Afsaneh Motamed Khorasani
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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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Implementing Process Controls for Optimum Performance of Cell-Based Assays
Gwendolyn Wise-Blackman
Recorded Duration : 60 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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Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Joy L. McElroy
Recorded Duration : 75 Minutes
Life Sciences > Pharmaceutical | Biotchnology | 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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Training Requirements and Practices to Assure QSR and ISO Compliance
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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CMS Training and Awareness
Kevin Thompson
Recorded Duration : 90 Minutes
Life Sciences > Healthcare

Kevin Thompson is a dedicated professional with a robust background in Governance, Risk Management, and Compliance (GRC). Currently serving as ...

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Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience
Edwin Waldbusser
Recorded Duration : 60 Minutes
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 ...
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