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The Most Common Problems in FDA Software Validation & Verification
John E. Lincoln
LIVE : July 09 , 2025 01:00 PM EDT
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...

Showing 341-350 of 705 items.
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Design and Implementation of Biologic Stability Program
Gwendolyn Wise-Blackman
Recorded Duration : 60 Minutes
Life Sciences > Biotechnology
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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Understanding and Preventing Cleanroom Contamination: Gaining and Re- establishing Control of your C...
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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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Quality by Design - Essential Techniques for Medical Devices
Susanne Manz
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background ...
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Minimize Medical Device Recalls – Understanding the Regulatory and Legal Requirements?
Charles H. Paul
Recorded Duration : 60 Minutes
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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Equipment Qualification & Process Validation
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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Use Six Sigma Wisely Instead of Continuing with Sick Sigma
Dev Raheja
Recorded Duration : 90 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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How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals an...
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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Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IN...
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
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Governance and Change Control according to GxP/GMP Requirements
Eleonora Babayants
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Galaxy Consulting Founder and President Eleonora Babayants is a documentation management professional and hands-on consultant with over 25 year...

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Essentials of Medical Device Reporting and Complaint Handling
Susanne Manz
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background ...
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