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Trial Master File (TMF): Meeting FDA Expectations
CAROLYN TROIANO
LIVE : March 29 , 2023 01:00 PM EDT
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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Medical Device Non-Product Software Validation Training
JOHN E. LINCOLN
LIVE : March 29 , 2023 10:30 AM 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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Risk Assessment in Medical Device Design
CHARLES H. PAUL
LIVE : March 31 , 2023 03:00 PM EST
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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Regulatory Requirements for Conducting an OOS Investigation
DANIELLE DELUCY
LIVE : March 31 , 2023 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | 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-Hour Virtual Seminar: Effective Cleaning Validation Procedures
JOY L. MCELROY
LIVE : April 03 , 2023 01:00 PM EDT
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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3-hr Virtual Seminar: Equipment Qualific...
JOY L. MCELROY
LIVE : April 04 , 2023 01:00 PM EDT
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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Impact Assessments and Risk Management for Change Control
ALAN GOLDEN
LIVE : April 04 , 2023 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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How to Prepare a Standard Operating Procedure
DR. AFSANEH MOTAMED KHORASANI
LIVE : April 05 , 2023 01:00 PM EDT
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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Gaining and Re-establishing Control of your Cleanroom
JOY L. MCELROY
LIVE : April 06 , 2023 03:00 PM EDT
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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GMP Auditing of Facilities Performing Cell-Based Methods
GWENDOLYN WISE-BLACKMAN
LIVE : April 07 , 2023 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 ...
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How FDA trains its Investigators to Review CAPA and How should you prepare
CHARLES H. PAUL
LIVE : April 10 , 2023 03:00 PM EST
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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(TMF)- Trial Master File: FDA Expectations from Sponsors and Sites
CAROLYN TROIANO
LIVE : April 11 , 2023 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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How to Prepare a 510(k) Submission
EDWIN WALDBUSSER
LIVE : April 12 , 2023 01:00 PM EDT
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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Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
CHARLES H. PAUL
LIVE : April 12 , 2023 01:00 PM EDT
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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The End of the Public Health Emergency is Near: What Your Health Care Organization Needs to do Now?
JOSEPH WOLFE
LIVE : April 18 , 2023 02:00 PM EDT
Life Sciences > Healthcare
Joseph Wolfe is an attorney with Hall Render, the largest healthcare-focused law firm in the country. Mr. Wolfe supports high-performing hospitals, health systems, medical gro...
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Stability Studies & Estimating Shelf Life with Regression Models
STEVEN WACHS
LIVE : April 19 , 2023 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. Steve has worked as a statistician at Ford Motor Company where he has...
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Policies, Process and Procedures
ROBERT PEOPLES
LIVE : April 19 , 2023 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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Technical Writing for a Traditional 510(k) Submission
JOHN E. LINCOLN
LIVE : April 21 , 2023 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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Technology Transfer 101
BARRY ROSENBLATT, PHD
LIVE : April 28 , 2023 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Dr. Rosenblatt is a subject matter expert in the chemistry and manufactur...
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Training for New Technical Writers
ROBERT PEOPLES
LIVE : April 28 , 2023 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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Computer Software Assurance: What exactl...
DAVID NETTLETON
LIVE : May 23 , 2023 03:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, E...

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