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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 111-120 of 133 items.
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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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Essentials of Validation – IQ, OQ, PQ
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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How to Prepare for and Host a FDA Inspection and Avoid 483’s (based on practical experience)
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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21 CFR Part 11-Electronic Records, Signatures - Compliance for Computer Systems Regulated by FDA
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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Understanding and Implementing a Quality by Design Program
Steven Laurenz
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled i...
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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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Regulations on Purchasing Controls for Medical Devices
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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Introduction to FDA and EU Medical Device Submissions
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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6-hour Virtual Seminar - FDA’s New Stringent Import Requirements Concerning International Conseque...
Casper (Cap) Uldriks
Recorded Duration : 360 Minutes
Life Sciences > Medical Devices
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device prog...
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Introduction to FDA and EU Medical Device Submissions
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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