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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 531-540 of 697 items.
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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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FDA Regulations for Marketing Dietary Supplements
Norma Skolnik
Recorded Duration : 60 Minutes
Life Sciences > Pharma | Biotech | Medical Devices
Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for th...
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FDA Regulation and Legislation of Cosmetics
Norma Skolnik
Recorded Duration : 60 Minutes
Life Sciences > Pharma | Biotech | Medical Devices
Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for th...
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FDA Regulations for Marketing & Labeling OTC Drugs In The U.S.
Norma Skolnik
Recorded Duration : 60 Minutes
Life Sciences > Pharma | Biotech | Medical Devices
Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for th...
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Federalwide Assurances: What Are They? Why and When Do I Need Them?
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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