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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 ...
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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : October 22 , 2025 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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Essentials of Validation – IQ, OQ, PQ
LIVE : October 23 , 2025 01:00 PM EDT
Life Sciences > Medical Devices
Showing 561-570 of 702 items.
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Understanding the Brazilian Regulatory Environment for Medical Devices
Claudia De Lucca Mano
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

With a law office in Sao Paulo, Brazil, since 1994, Claudia Thereza de Lucca Mano is a practicing attorney and consultant, who specializes on B...

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General Data Protection Regulation (GDPR): Compliance for Clinical Trials
Dr. Laura Brown
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Laura Brown is an independent QA and Training Consultant and Director of the MSc in Clinical Research, School of Pharmacy at the University...

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Developing a Quality Management System – Where Do I Begin?
Marie Dorat
Recorded Duration : 75 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years  experience, in the Pharmaceutical/Medical Device...
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Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance
Sarah Fowler-Dixon
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for huma...
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Unique Device Identifier (UDI) Rule Implementation
Marie Dorat
Recorded Duration : 75 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years  experience, in the Pharmaceutical/Medical Device...
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The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors look...
Dr. Charles H Pierce
Recorded Duration : 90 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory

Charles H Pierce is Medical Director of Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) throug...

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Compliant Management Controls under 21 CFR 820 and ISO 13485
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Equipment Validation, Tracking, Calibration and Preventive Maintenance
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Biopharmaceutical Aspects of the Active Pharmaceutical Ingredient and Pharmaceutical Equivalence
Leon Shargel
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Leon Shargel, Ph.D., R.Ph., is Manager and Founder of Applied Biopharmaceutics LLC, a pharmaceutical consulting company and holds academic appointments as Affiliate Professor,...
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An Environmental Microbiologist View of Uncertainty of Measurement
Michael Brodsky
Recorded Duration : 60 Minutes
Life Sciences > Biotechnology

Michael has a post-graduate degree from the University of Toronto, School of Hygiene and Tropical Medicine and been an Environmental Microbiolo...

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