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Showing 1-4 of 4 items.
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Essentials of Validation – IQ, OQ, PQ
LIVE : September 19 , 2024 01:00 PM EDT
Life Sciences > Medical Devices
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Stability and Shelf Life of Medical Device
John E. Lincoln
LIVE : September 27 , 2024 01:00 PM 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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Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience
Edwin Waldbusser
LIVE : October 02 , 2024 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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Medical Device Non-Product Software Validation Training
John E. Lincoln
LIVE : October 04 , 2024 01:00 PM 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...

Showing 61-70 of 138 items.
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3-hr Virtual Seminar: Design Controls for Medical Devices
Recorded Duration : 180 Minutes
Life Sciences > Medical Devices
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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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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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Implementing IEC 62304 for Safe and Effective Medical Device Software
Nancy Knettell
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulato...

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Software FMEA for Medical Devices
Dev Raheja
Recorded Duration : 90 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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ISO 13485:2016 - What are the hot topics and changes?
Dr. Frank Stein
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac su...

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ISO 13485:2016 - What are the hot topics and changes?
Dr. Frank Stein
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac su...

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Essentials of Validation – IQ, OQ, PQ
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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Minimize Medical Device Recalls – Understanding the Regulatory and Legal Requirements?
Charles H. Paul
Recorded Duration : 60 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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