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Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configura...
Jose Mora
LIVE : May 13 , 2024 01:00 PM EST
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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Write it Right – Well Written Procedures are Essential for QMS Effectiveness
Joy L. McElroy
LIVE : May 14 , 2024 01:00 PM EST
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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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...
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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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The Role of Logbooks and Recordkeeping in Identifying Root Causes
John C. Fetzer
LIVE : May 20 , 2024 03:00 PM EDT
Life Sciences > Laboratory
John C. Fetzer, has had over 30 year experience in GC and GC-MS methods development. He has authored or co-authored over 50 peer-reviewed papers on chromatography, has served ...
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3-hr Virtual Seminar: Validation and Part 11 Compliance of Computer Systems
Joy L. McElroy
LIVE : May 21 , 2024 01:00 PM EDT
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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Writing and Enforcing Effective Standard Operating Procedures (SOP) and Work Instructions
Joy L. McElroy
LIVE : May 29 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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GMP Auditing of Facilities Performing Cell-Based Methods
Gwendolyn Wise-Blackman
LIVE : May 31 , 2024 01:00 PM EDT
Life Sciences > Pharmaceutical | Biotchnology | Laboratory
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly ...
Showing 41-50 of 685 items.
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4-Hour Virtual Training: How to Respond to an FDA Investigation
Joy L. McElroy
Recorded Duration : 240 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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GMP Complaint Systems, FDA's Adverse Event Reporting & Product Recalls
Joy L. McElroy
Recorded Duration : 75 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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Environmental Monitoring - Setting Accurate Alert and Action Limits
Joy L. McElroy
Recorded Duration : 90 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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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Regulations on Purchasing Controls for Medical Devices
Recorded Duration : 90 Minutes
Life Sciences > Medical Devices
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Stability and Shelf Life of Medical Device
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 to Prepare a Standard Operating Procedure
Dr. Afsaneh Motamed Khorasani
Recorded Duration : 60 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical sc...

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Process Validation – Principles and Protocols
Jeff Kasoff
Recorded Duration : 60 Minutes
Life Sciences > Medical Device | Diagnostic | Pharmaceutical | Biologics fields
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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How to Create a Medical Software Development File according ISO 62304?
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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Problem Solving - Root Cause Analysis in Pharma Manufacturing
Joy L. McElroy
Recorded Duration : 75 Minutes
Life Sciences > Pharmaceutical

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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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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