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Showing 1-3 of 3 items.
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Understanding Combination Products: Navigating the Rules and Regulations
Charles H. Paul
LIVE : April 30 , 2024 01:00 PM EDT
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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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 ...
Showing 11-20 of 132 items.
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Qualification and Control of Contract Manufacturer Organizations 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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Essentials of Validation – IQ, OQ, PQ
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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US FDA Guidance Documents: Device Changes and the 510(k)
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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How FDA trains its Investigators to Review CAPA and How should you prepare
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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3-hr Virtual Seminar: Validation and Part 11 Compliance of Computer Systems
Joy L. McElroy
Recorded Duration : 180 Minutes
Life Sciences > Medical Devices

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. ...

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How to Write Procedures to Avoid Human Errors
Ginette Collazo, PH.D
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...

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Medical Device Non-Product Software Validation Training
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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Medical Device Software: Verification, Validation & Compliance
Recorded Duration : 75 Minutes
Life Sciences > Medical Devices
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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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US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485
Meredith Crabtree
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

Meredith Crabtree has over 25 years experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device,...

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