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Showing 11-11 of 11 items.
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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 11-20 of 684 items.
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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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4-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst...
Joy L. McElroy
Recorded Duration : 240 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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The FDA Inspection: From SOP to 483
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
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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PK/PD Studies in Drug Discovery and Development
Dr. Stefano Persiani
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmac...

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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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Sunshine Act Reporting – Clarification for Clinical Research
Danielle DeLucy
Recorded Duration : 75 Minutes
Life Sciences > Clinical | Biotechnology | 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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3-hr Virtual Seminar: Understanding Requirements of a Bioanalytical Method Validation
Gwendolyn Wise-Blackman
Recorded Duration : 180 Minutes
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 ...
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3-hr Virtual Seminar: Design Controls for Medical Devices
Susanne Manz
Recorded Duration : 180 Minutes
Life Sciences > Medical Devices
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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Investigator Initiated Trials- What Are We Doing to Ensure Human Subject Protection?
Dr. Nagina Parmar
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Nagina Parmar has 15 years of clinical research experience as a certified clinicalresearch professional in academia and hospital. Her exper...

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Verification and Validation – Product, Process or Equipment and QMS Software
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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