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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 601-610 of 697 items.
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Bioavailability and Bioequivalence Studies submitted in NDAs and INDs
Stephanie Cooke
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Stephanie Cooke is the President & CEO of Cooke Consulting, Inc., using her 20 years of experience to provide global consulting services in...

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Challenges for Data Collection in Clinical Trials for Low Cost Wearable Monitors
Sarah Fowler-Dixon
Recorded Duration : 60 Minutes
Life Sciences > Clinical Trial
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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Regulatory Compliance in the Pharmaceutical Supply Chain
Angela Bazigos
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roc...
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Post Marketing and Regulatory Compliance
Peggy J Berry
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also pro...
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Complaint Handling in Compliance with FDA and ISO Regulations
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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Conquering Complaint Handling in Compliance with FDA and ISO Regulations
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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GMP Requirements for Records and Reports
Peggy J Berry
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also pro...
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Auditing Quality Suppliers and Vendors
Joy L. McElroy
Recorded Duration : 90 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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Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Joy L. McElroy
Recorded Duration : 90 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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Protocol Deviations: Documenting, Managing, and Reporting
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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