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Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Repor...
Charles H. Paul
LIVE : August 06 , 2024 01:00 PM EDT
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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CMO Supplier Quality Agreements - Comply with new FDA & EU GMP Guidelines for Contract Drug Manufact...
LIVE : August 16 , 2024 03:00 PM EDT
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
Showing 1-10 of 179 items.
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Writing Validation Master Plans: Best Practices for Authoring a Compliant Document
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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Write it Right – Well Written Procedures are Essential for QMS Effectiveness
Joy L. McElroy
Recorded Duration : 60 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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Impact Assessments and Risk Management for Change Control
Alan Golden
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Ab...

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Human Factors-Usability Based on ISO 62366
John E. Lincoln
Recorded Duration : 60 Minutes
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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Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configura...
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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The Human Error Tool Box: A Practical Approach to Human Error
Dr. Ginette Collazo
Recorded Duration : 90 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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6-hr Virtual Seminar: Medical Device Regulations and Evolving Requirements: Post Market Surveillance...
Recorded Duration : 360 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Carolyn Troiano
Recorded Duration : 360 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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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
Susanne Manz
Recorded Duration : 360 Minutes
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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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
John E. Lincoln
Recorded Duration : 90 Minutes
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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