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Showing 1-8 of 8 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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The DHF, DMR, DHR, and Technical Documents File
John E. Lincoln
LIVE : January 09 , 2025 01:00 PM EST
Life Sciences > Medical Devices

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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Training for New Technical Writers
Robert Peoples
LIVE : January 13 , 2025 01:00 PM EST
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

After obtaining a B.S. and an M.S. in Chemistry from Tuskegee University, Robert Peoples joined the pharmaceutical industry as a Research Chemi...

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Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Jose Mora
LIVE : January 16 , 2025 01:00 PM EST
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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Write it Right – Well Written Procedures are Essential for QMS Effectiveness
Joy L. McElroy
LIVE : January 17 , 2025 01:00 PM EST
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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3-hr Virtual Seminar: Equipment Qualification and Validation of Processes in the Manufacturing Envir...
Joy L. McElroy
LIVE : January 22 , 2025 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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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 691-697 of 697 items.
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Getting Ready for an FDA Inspection
Felicia Angus
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical
Felicia Angus is passionate quality professional with over 23 years of pharmaceutical experience in the clinical, solid dosage, API, sterile and biological industries and over...
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21 CFR Part 11-Electronic Records, Signatures - Compliance for Computer Systems Regulated by FDA
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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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ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration
Jose Mora
Recorded Duration : 90 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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3-hr Virtual Seminar: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industrie...
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Biotechnology

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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An Environmental Microbiologist’s View of Uncertainty of Measurement
Michael Brodsky
Recorded Duration : 60 Minutes
Life Sciences > Laboratory

Michael has a post-graduate degree from the University of Toronto, School of Hygiene and Tropical Medicine and been an Environmental Microbiolo...

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Is it Method Verification or Validation, or Just Semantics
Michael Brodsky
Recorded Duration : 60 Minutes
Life Sciences > Laboratory

Michael has a post-graduate degree from the University of Toronto, School of Hygiene and Tropical Medicine and been an Environmental Microbiolo...

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Microbiological Risk Analysis and HACCP
Michael Brodsky
Recorded Duration : 60 Minutes
Life Sciences > Laboratory

Michael has a post-graduate degree from the University of Toronto, School of Hygiene and Tropical Medicine and been an Environmental Microbiolo...

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