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Trial Master File (TMF): Meeting FDA Expectations

Carolyn Troiano

Recorded Duration : 90 Minutes

Life Sciences > Clinical Trial

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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The Human Error Tool Box: A Practical Approach to Human Error

Dr. Ginette Collazo

Recorded Duration : 90 Minutes

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

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines ...

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How to Handle the Most Common Problems Related to FDA Software Validation and Verification

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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How to Prepare a Standard Operating Procedure

Dr. Afsaneh Motamed Khorasani

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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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Writing and Enforcing Effective Standard Operating Procedures (SOP) and Work Instructions

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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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare

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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3-hr Virtual Seminar: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industrie...

Joy L. McElroy

Recorded Duration : 180 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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HVAC and GMP Environmental Control for Pharmaceutical Cleanrooms

Recorded Duration : 60 Minutes

Life Sciences > Pharmaceutical

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Medical Device Complaints & CAPA

Edwin Waldbusser

Recorded Duration : 60 Minutes

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

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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Environmental Monitoring - Setting Accurate Alert and Action Limits

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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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

Trial Master File (TMF): Meeting FDA Expectations

Carolyn Troiano

Recorded Duration : 90 Minutes

The Human Error Tool Box: A Practical Approach to Human Error

Dr. Ginette Collazo

Recorded Duration : 90 Minutes

How to Handle the Most Common Problems Related to FDA Software Validation and Verification

Carolyn Troiano

Recorded Duration : 90 Minutes

How to Prepare a Standard Operating Procedure

Dr. Afsaneh Motamed Khorasani

Recorded Duration : 60 Minutes

Writing and Enforcing Effective Standard Operating Procedures (SOP) and Work Instructions

Joy L. McElroy

Recorded Duration : 90 Minutes

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare

Jeff Kasoff

Recorded Duration : 60 Minutes

3-hr Virtual Seminar: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industrie...

Joy L. McElroy

Recorded Duration : 180 Minutes

HVAC and GMP Environmental Control for Pharmaceutical Cleanrooms

Recorded Duration : 60 Minutes

Medical Device Complaints & CAPA

Edwin Waldbusser

Recorded Duration : 60 Minutes

Environmental Monitoring - Setting Accurate Alert and Action Limits

Joy L. McElroy

Recorded Duration : 90 Minutes

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