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Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation

Dev Raheja

Recorded Duration : 90 Minutes

Life Sciences > Medical Devices

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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The FDA Inspection Process: From SOP to 483

Jeff Kasoff

Recorded Duration : 60 Minutes

Life Sciences > Medical Devices

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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Implementation of Risk Evaluation and Mitigation Strategy (REMS) - What do you need to do now?

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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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Equipment Qualification and Process Validation

Dr. Loren Gelber

Recorded Duration : 90 Minutes

Life Sciences > Medical Devices

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC d...

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EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials

Dr. Laura Brown

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Dr. Laura Brown is an independent QA and Training Consultant and Director of the MSc in Clinical Research, School of Pharmacy at the University...

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FDA Regulations for OTC Drugs

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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FDA’s Mandatory Import Requirements

Casper (Cap) Uldriks

Recorded Duration : 60 Minutes

Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device prog...

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Due Diligence of Quality Systems for Medical Device Companies

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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Validation of Complex Cell-Based Potency Methods

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

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 ...

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Lean Supplier Management in Compliance with FDA and ISO-13485 Requirements

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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The Most Common Problems in FDA Software Validation & Verification

John E. Lincoln

LIVE : July 09 , 2025 01:00 PM EDT

Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation

Dev Raheja

Recorded Duration : 90 Minutes

The FDA Inspection Process: From SOP to 483

Jeff Kasoff

Recorded Duration : 60 Minutes

Implementation of Risk Evaluation and Mitigation Strategy (REMS) - What do you need to do now?

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

Equipment Qualification and Process Validation

Dr. Loren Gelber

Recorded Duration : 90 Minutes

EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials

Dr. Laura Brown

Recorded Duration : 60 Minutes

FDA Regulations for OTC Drugs

Joy L. McElroy

Recorded Duration : 90 Minutes

FDA’s Mandatory Import Requirements

Casper (Cap) Uldriks

Recorded Duration : 60 Minutes

Due Diligence of Quality Systems for Medical Device Companies

Susanne Manz

Recorded Duration : 90 Minutes

Validation of Complex Cell-Based Potency Methods

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

Lean Supplier Management in Compliance with FDA and ISO-13485 Requirements

Jeff Kasoff

Recorded Duration : 60 Minutes

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