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21 CFR Part 11-Electronic Records, Signatures - Compliance for Computer Systems Regulated by FDA

Carolyn Troiano

Recorded Duration : 90 Minutes

Life Sciences > Medical Devices

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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US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485

Meredith Crabtree

Recorded Duration : 90 Minutes

Life Sciences > Medical Devices

Meredith Crabtree has over 25 years experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device,...

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IQ, OQ, PQ in the Verification and Validation Process

John E. Lincoln

Recorded Duration : 90 Minutes

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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Medical Devices – US & International Regulatory Compliance and Regulatory Affairs

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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4 Hours Virtual Seminar: Risk Management in the Medical Device Design Process

Charles H. Paul

Recorded Duration : 240 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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US FDA's AI/ ML Framework for Medical Devices

John E. Lincoln

Recorded Duration : 90 Minutes

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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Medical Device Software 62304 Compliance

Carolyn Troiano

Recorded Duration : 90 Minutes

Life Sciences > Medical Devices

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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Software Validation & Testing – Regulatory Requirements

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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Master Verification and Validation Planning per US FDA and EU MDR / ISO

John E. Lincoln

Recorded Duration : 90 Minutes

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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Medical Devices Periodic Safety Update Report (PSUR)

John E. Lincoln

Recorded Duration : 90 Minutes

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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Risk Based Design Control

Edwin Waldbusser

LIVE : May 15 , 2024 01:00 PM EDT

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

Jeff Kasoff

LIVE : May 16 , 2024 01:00 PM EDT

21 CFR Part 11-Electronic Records, Signatures - Compliance for Computer Systems Regulated by FDA

Carolyn Troiano

Recorded Duration : 90 Minutes

US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485

Meredith Crabtree

Recorded Duration : 90 Minutes

IQ, OQ, PQ in the Verification and Validation Process

John E. Lincoln

Recorded Duration : 90 Minutes

Medical Devices – US & International Regulatory Compliance and Regulatory Affairs

Charles H. Paul

Recorded Duration : 60 Minutes

4 Hours Virtual Seminar: Risk Management in the Medical Device Design Process

Charles H. Paul

Recorded Duration : 240 Minutes

US FDA's AI/ ML Framework for Medical Devices

John E. Lincoln

Recorded Duration : 90 Minutes

Medical Device Software 62304 Compliance

Carolyn Troiano

Recorded Duration : 90 Minutes

Software Validation & Testing – Regulatory Requirements

Dev Raheja

Recorded Duration : 90 Minutes

Master Verification and Validation Planning per US FDA and EU MDR / ISO

John E. Lincoln

Recorded Duration : 90 Minutes

Medical Devices Periodic Safety Update Report (PSUR)

John E. Lincoln

Recorded Duration : 90 Minutes

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