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3-hr Virtual Seminar: Validation and Part 11 Compliance of Computer Systems

Joy L. McElroy

Recorded Duration : 180 Minutes

Life Sciences > Medical Devices

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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Developing & Managing a Trial Master File for FDA-Regulated Clinical Testing

Carolyn Troiano

Recorded Duration : 90 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

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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How to Prepare For and Host a FDA Inspection and Respond to 483’s

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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Good Documentation Guideline (Chapter <1029> USP)

Dr. Afsaneh Motamed Khorasani

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical | Biotchnology | Laboratory

Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical sc...

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FDA Audit Best Practices - Dos and Don'ts

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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Write it Right – Well Written Procedures are Essential for QMS Effectiveness

Joy L. McElroy

Recorded Duration : 60 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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3-hr Virtual Seminar: Equipment Qualification and Validation of Processes in the Manufacturing Envir...

Joy L. McElroy

Recorded Duration : 180 Minutes

Life Sciences > Pharmaceutical

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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Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Jose Mora

Recorded Duration : 90 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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Training for New Technical Writers

Robert Peoples

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

After obtaining a B.S. and an M.S. in Chemistry from Tuskegee University, Robert Peoples joined the pharmaceutical industry as a Research Chemi...

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The DHF, DMR, DHR, and Technical Documents File

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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Recorded

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

3-hr Virtual Seminar: Validation and Part 11 Compliance of Computer Systems

Joy L. McElroy

Recorded Duration : 180 Minutes

Developing & Managing a Trial Master File for FDA-Regulated Clinical Testing

Carolyn Troiano

Recorded Duration : 90 Minutes

How to Prepare For and Host a FDA Inspection and Respond to 483’s

Edwin Waldbusser

Recorded Duration : 60 Minutes

Good Documentation Guideline (Chapter <1029> USP)

Dr. Afsaneh Motamed Khorasani

Recorded Duration : 60 Minutes

FDA Audit Best Practices - Dos and Don'ts

Charles H. Paul

Recorded Duration : 60 Minutes

Write it Right – Well Written Procedures are Essential for QMS Effectiveness

Joy L. McElroy

Recorded Duration : 60 Minutes

3-hr Virtual Seminar: Equipment Qualification and Validation of Processes in the Manufacturing Envir...

Joy L. McElroy

Recorded Duration : 180 Minutes

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Jose Mora

Recorded Duration : 90 Minutes

Training for New Technical Writers

Robert Peoples

Recorded Duration : 60 Minutes

The DHF, DMR, DHR, and Technical Documents File

John E. Lincoln

Recorded Duration : 90 Minutes

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