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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 621-630 of 697 items.
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Investigational Product Accountability Best Practices
Sarah Fowler-Dixon
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for huma...
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Patients' Medical Records: Disposition of Records and Records Retention, Including Electronic Record...
Mark Brengleman
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
Mark worked as the assigned counsel to numerous health professions licensure boards as an Assistant Attorney General for the Commonwealth of Kentucky. Moving to private practi...
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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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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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How to Prepare for and Host a FDA Inspection and Avoid 483’s (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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3-hr Virtual Seminar: Understanding Requirements of a Bioanalytical Method Validation
Gwendolyn Wise-Blackman
Recorded Duration : 180 Minutes
Life Sciences > 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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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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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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Understanding and Implementing a Quality by Design Program
Steven Laurenz
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled i...
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Vendor Qualification - Evaluating Vendors & Understanding their Capabilities
Todd Graham
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
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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