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The Most Common Problems in FDA Software Validation & Verification

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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Human Factors-Usability Based on ISO 62366

Recorded Duration : 60 Minutes

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

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21 CFR Part 820 - Quality System Regulation - Principles of Lean Documents and Lean Configuration

Jose Mora

Recorded Duration : 75 Minutes

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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Essentials of Validation – IQ, OQ, PQ

Recorded Duration : 90 Minutes

Life Sciences > Medical Devices

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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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4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance

Carolyn Troiano

Recorded Duration : 240 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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Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience

Edwin Waldbusser

Recorded Duration : 60 Minutes

Life Sciences > Medical Devices

Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development ...

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How FDA trains its Investigators to Review CAPA and How should you prepare

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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Technology Transfer 101

Barry Rosenblatt, PhD

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Dr. Rosenblatt is a subject matter expert in the chemistry and manufactur...

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Good Documentation Practices

Danielle DeLucy

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in o...

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Understanding and Implementing a Technology Transfer Process

Steven Laurenz

LIVE : September 23 , 2025 01:00 PM EDT

GMPs for Medical Devices and Key Medical Device Observations

Charles H. Paul

LIVE : September 24 , 2025 01:00 PM EDT

The Most Common Problems in FDA Software Validation & Verification

John E. Lincoln

Recorded Duration : 90 Minutes

Human Factors-Usability Based on ISO 62366

Recorded Duration : 60 Minutes

21 CFR Part 820 - Quality System Regulation - Principles of Lean Documents and Lean Configuration

Jose Mora

Recorded Duration : 75 Minutes

Essentials of Validation – IQ, OQ, PQ

Recorded Duration : 90 Minutes

Validation of Complex Cell-Based Potency Methods

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance

Carolyn Troiano

Recorded Duration : 240 Minutes

Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience

Edwin Waldbusser

Recorded Duration : 60 Minutes

How FDA trains its Investigators to Review CAPA and How should you prepare

Charles H. Paul

Recorded Duration : 60 Minutes

Technology Transfer 101

Barry Rosenblatt, PhD

Recorded Duration : 60 Minutes

Good Documentation Practices

Danielle DeLucy

Recorded Duration : 60 Minutes

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