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Showing 1-6 of 6 items.
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6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications
Carolyn Troiano
LIVE : May 17 , 2024 11:00 AM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : May 20 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
John E. Lincoln
LIVE : May 30 , 2024 01:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
Susanne Manz
LIVE : June 18 , 2024 11:00 AM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Carolyn Troiano
LIVE : June 19 , 2024 11:00 AM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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6-hr Virtual Seminar: Medical Device Regulations and Evolving Requirements: Post Market Surveillance...
LIVE : June 25 , 2024 11:00 AM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Showing 131-140 of 176 items.
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Best Practices in Preparation for an FDA Computer System Audit
Carolyn Troiano
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Regulatory Inspections – How to Prepare for a Visit from an FDA Auditor
Denise Wrestler, ASQ CQE, CQA
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

With over 15 years of experience

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Introduction to Root Cause Investigation for CAPA
Vanessa Lopez
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Vanessa Lopez is senior principle quality,  regulatory and compliance consultant. She has held a wide variety of leadership roles in the m...

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How to Make Design Part of Your Product Development DNA
Tom Kramer
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Tom Kramer, president and CEO of Kablooe Design, has been a product innovator for over 26

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Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration
Jose Mora
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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Effective and Practical use of FMEA For Risk-Based Approach to Computer Systems Validation
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

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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Designing Medical Devices for Safety, Reliability, and Maintainability
Dev Raheja
Recorded Duration : 75 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies ev...
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Achieving Regulatory Compliance in the Life Sciences - Step by Step
Charles H. Paul
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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2-hr Virtual Seminar: Advance Preparation and Planning for Notified Bodies Unannounced Audits
Vanessa Lopez
Recorded Duration : 120 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Vanessa Lopez is senior principle quality,  regulatory and compliance consultant. She has held a wide variety of leadership roles in the m...

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Advanced Course on Lean Documents, Lean Configuration and Document Control
Jose Mora
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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