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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 71-80 of 138 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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Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
Dr. Frank Stein
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac su...

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Risk and Its Impact on Medical Device Design
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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Software Documentation for a Successful 510k Submission
Nancy Knettell
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices

Nancy Knettell, Founder and Principal at Software510K, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulato...

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2-hr Virtual Seminar: Advanced Root Cause Analysis and CAPA Investigations
Susanne Manz
Recorded Duration : 120 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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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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How to Implement the ISO 13485 in Your Company?
Dr. Frank Stein
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac su...

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Medical Device Single Audit Program (MDSAP) - A New Face of Audit
Parul Chansoria, RAC
Recorded Duration : 60 Minutes
Life Sciences > Medical Devices
Parul is a Medical Device Professional with successful experience in initiation & implementation of Quality & Regulatory activities for different phases of a medical p...
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Top Process Validation Mistakes - And How to Avoid Them
Susanne Manz
Recorded Duration : 60 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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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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