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European Union Device Regulation (EU MDR)
Edwin Waldbusser
LIVE : May 01 , 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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Risk Based Design Control
Edwin Waldbusser
LIVE : May 15 , 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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Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
Jeff Kasoff
LIVE : May 16 , 2024 01:00 PM EDT
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...
Showing 121-130 of 133 items.
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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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FDA vs Health Canada
Rachelle D'Souza
Recorded Duration : 60 Minutes
Life Sciences > Healthcare
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial maste...
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FDA vs Health Canada
Rachelle D'Souza
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national companies. Her expertise also includes clinical trial maste...
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Understanding 21 CFR Part 11 Validation - Procedures for Controlling Electronic Signatures and Elect...
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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Essentials of Validation – IQ, OQ, PQ
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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Understanding Combination Products: Navigating the Rules and Regulations
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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Corrective and Preventive Action utilizing the 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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Two New FDA Draft Guidance Documents: Medical Devices and 510k Submission
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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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Essentials of Medical Device Reporting and Complaint Handling
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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Regulations on Purchasing Controls for Medical Devices
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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