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Training Requirements and Practices to Assure QSR and ISO Compliance
Jeff Kasoff
LIVE : October 15 , 2024 01:00 PM EDT
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...
Showing 1-10 of 181 items.
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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
John E. Lincoln
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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Impact Assessments and Risk Management for Change Control
Alan Golden
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Ab...

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Human Factors-Usability Based on ISO 62366
John E. Lincoln
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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How to Handle the Most Common Problems Related to FDA Software Validation and Verification
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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The 11 Must-Have Documents Of software Verification and Validation
John E. Lincoln
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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GMPs for Medical Devices and Key Medical Device Observations
Charles H. Paul
Recorded Duration : 60 Minutes
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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3-hr Virtual Seminar: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industrie...
Joy L. McElroy
Recorded Duration : 180 Minutes
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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CMO Supplier Quality Agreements - Comply with new FDA & EU GMP Guidelines for Contract Drug Manufact...
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Repor...
Charles H. Paul
Recorded Duration : 60 Minutes
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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Writing Validation Master Plans: Best Practices for Authoring a Compliant Document
Joy L. McElroy
Recorded Duration : 90 Minutes
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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