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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 281-290 of 702 items.
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Quality Control for Analytical Materials used in Microbiology Laboratories
Michael Brodsky
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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FDA’s Latest UDI Labeling Requirements
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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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
Recorded Duration : 120 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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Production and Process Controls for Medical Devices
Susanne Manz
Recorded Duration : 90 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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21 CFR Part 820 - Quality System Regulation - Principles of Lean Documents and Lean Configuration
Jose Mora
Recorded Duration : 75 Minutes
Life Sciences > Medical Devices
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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Conducting an Effective Software Validation of Medical Device to Meet FDA Requirements
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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Remote Auditing of Medical Device Suppliers During Covid-19
Susanne Manz
Recorded Duration : 90 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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Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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3-hr Virtual Seminar: Understanding and Controlling Biofilm
T C Soli
Recorded Duration : 180 Minutes
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer produc...
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Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation
Dev Raheja
Recorded Duration : 75 Minutes
Life Sciences > Medical Devices
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies ev...
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