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Essentials of Validation – IQ, OQ, PQ
LIVE : October 15 , 2025 01:00 PM EDT
Life Sciences > Medical Devices
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Good Documentation Guideline (Chapter <1029> USP)
Dr. Afsaneh Motamed Khorasani
LIVE : October 16 , 2025 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | 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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How to Prepare For and Host a FDA Inspection and Respond to 483’s
Edwin Waldbusser
LIVE : October 16 , 2025 01:00 PM EDT
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 ...
Showing 201-210 of 703 items.
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Objectionable Microorganisms in Biopharmaceutical Manufacturing
Carl Patterson, MS, SSGB, SSBB
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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

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Verification and Validation of Production Equipment Hardware / Software
John E. Lincoln
Recorded Duration : 90 Minutes
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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Predicting Product Life with Reliability Analysis Methods
Steven Wachs
Recorded Duration : 90 Minutes
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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3-hr Virtual Seminar: Fundamentals of CGMPs
Charles H. Paul
Recorded Duration : 180 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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Auditing Laboratories Conducting Assays Supporting Biologics
Gwendolyn Wise-Blackman
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | 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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Risk-based Design Control - The New Paradigm for Medical Device Design
Jose Mora
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences ind...
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Preventing Medical Device Recalls
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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eCTD Submissions of IND-NDA to the US FDA, EU and Canada
Peggy J Berry
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also pro...
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Virtual Site Audits for FDA Regulated Industries
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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Effective Document Management for Pharma, Biotech & Medical Device
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharma | Biotech | Medical Devices

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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