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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 41-50 of 134 items.
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FDA Establishment Inspections – What to Expect
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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Measuring and Understanding Cognitive Overload and Human Error
Dr. Ginette Collazo
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines ...
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Medical Device Cybersecurity Following Latest FDA Guidance
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 and Implementing a Quality by Design Program
Steven Laurenz
Recorded Duration : 60 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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How to Deal with Medical Device Tracking Requirements
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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FDA’s Plan for Modernizing the 510(k) Pathway – Meet the New Expectations
John E. Lincoln
Recorded Duration : 90 Minutes
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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Data Integrity for medical device development companies & Part 11 under the FDA QSR
Don Hurd
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Don Hurd has over 35 years of experience in supporting development of applications both in the commercial space and in regulated industries, in...

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Writing Effective SOPs (Standard Operating Procedures)
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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Best Practices for Purchasing and Supplier Controls in the Medical Device Industry
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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FDA vs Health Canada
Rachelle D'Souza
Recorded Duration : 75 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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