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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 81-90 of 138 items.
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The Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under on...
Meena Chettiar
Recorded Duration : 75 Minutes
Life Sciences > Medical Devices

Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A.SC in Chemical Engineering from University ...

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Non-conforming Material and Failure Investigation
Susanne Manz
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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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Preparing for FDA Audits and Responding to FDA 483s in Pharmaceutical and Medical Device Industries
Meena Chettiar
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A.SC in Chemical Engineering from University ...

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ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration
Jose Mora
Recorded Duration : 90 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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ISO 13485: Medical Device Quality Management Systems
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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Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation
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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The FDA Inspection Process: From SOP to 483
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
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 Qualification and Process Validation
Dr. Loren Gelber
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC d...
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Due Diligence of Quality Systems for Medical Device Companies
Susanne Manz
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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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6-Hour Virtual Seminar - Evolution of the Quality Management System - How to go from Surviving to Th...
Susanne Manz
Recorded Duration : 360 Minutes
Life Sciences > Medical Devices
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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