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Showing 1-10 of 13 items.
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(TMF)- Trial Master File: FDA Expectations from Sponsors and Sites
Carolyn Troiano
LIVE : September 18 , 2024 01:00 PM EDT
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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Human Factors-Usability Based on ISO 62366
John E. Lincoln
LIVE : September 18 , 2024 01:00 PM EDT
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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Essentials of Validation – IQ, OQ, PQ
LIVE : September 19 , 2024 01:00 PM EDT
Life Sciences > Medical Devices
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Impact Assessments and Risk Management for Change Control
Alan Golden
LIVE : September 23 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Ab...

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3-Hour Virtual Seminar: SOP Writing, Training and Compliance in the Pharmaceutical Industry
LIVE : September 23 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
John E. Lincoln
LIVE : September 24 , 2024 01:00 PM EDT
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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Gaining and Re-establishing Control of your Cleanroom
Joy L. McElroy
LIVE : September 25 , 2024 03:00 PM EST
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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Stability and Shelf Life of Medical Device
John E. Lincoln
LIVE : September 27 , 2024 01:00 PM EDT
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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Implementing Policies, Process and Procedures
Robert Peoples
LIVE : September 30 , 2024 01:00 PM EDT
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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Pharmaceutical Water Systems - Validation, Monitoring, and Analyzing Data Results
Carl Patterson, MS, SSGB, SSBB
LIVE : October 01 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | Laboratory

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, Ca...

Showing 1-10 of 689 items.
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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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Good Clinical Practices: Practical Applications and Implementation, Audit Preparation
Marina Malikova
Recorded Duration : 90 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investiga...

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HIPAA Security Awareness Training
Kevin Thompson
Recorded Duration : 90 Minutes
Life Sciences > Healthcare

Kevin Thompson is a dedicated professional with a robust background in Governance, Risk Management, and Compliance (GRC). Currently serving as ...

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Web Writing for 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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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 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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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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The 11 Must-Have Documents Of software Verification and Validation
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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GMPs for Medical Devices and Key Medical Device Observations
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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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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