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Showing 1-8 of 8 items.
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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Dr. Afsaneh Motamed Khorasani
LIVE : April 22 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Joy L. McElroy
LIVE : April 23 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | 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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Impact Assessments and Risk Management for Change Control
Alan Golden
LIVE : April 24 , 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-hr Virtual Seminar: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industrie...
Joy L. McElroy
LIVE : April 25 , 2024 01:00 PM EDT
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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Human Factors-Usability Based on ISO 62366
John E. Lincoln
LIVE : April 26 , 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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Understanding the Five Pillars of 5S for Operators
Dr. Ginette Collazo
LIVE : April 29 , 2024 01:00 PM EDT
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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Understanding Combination Products: Navigating the Rules and Regulations
Charles H. Paul
LIVE : April 30 , 2024 01:00 PM EDT
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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GMP Auditing of Facilities Performing Cell-Based Methods
Gwendolyn Wise-Blackman
LIVE : May 31 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
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 ...
Showing 41-50 of 685 items.
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Risk Assessment in Medical Device Design
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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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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Human Error Risk Management In Medical Device Design
Charles H. Paul
Recorded Duration : 90 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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Clinical Process Improvement
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Clinical | Biotechnology | 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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Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IN...
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
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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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Essentials of Validation – IQ, OQ, PQ
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
Susanne Manz
Recorded Duration : 360 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background ...
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Policies, Process and Procedures
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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