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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
John E. Lincoln
LIVE : December 05 , 2023 01:00 PM EST
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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Bioassay Development and Method Validation
Gwendolyn Wise-Blackman
LIVE : December 06 , 2023 03:00 PM EST
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 ...
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How to Handle the Most Common Problems Related to FDA Software Validation and Verification
Carolyn Troiano
LIVE : December 07 , 2023 01:00 PM EST
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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Problem Solving - Root Cause Analysis in Pharma Manufacturing
Joy L. McElroy
LIVE : December 07 , 2023 01:00 PM EST
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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Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
Charles H. Paul
LIVE : December 14 , 2023 01:00 PM EST
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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FDA Compliance and Clinical Trial Computer System Validation
Carolyn Troiano
LIVE : December 20 , 2023 01:00 PM EST
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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Human Factors-Usability Based on ISO 62366
John E. Lincoln
LIVE : December 20 , 2023 01:00 PM EST
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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5 Key Components of Good Manufacturing Practices to obtain cGMP Certification
Meredith Crabtree
LIVE : January 18 , 2024 03:00 PM EST
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory

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

Showing 1-10 of 682 items.
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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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Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Repor...
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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3-hr Virtual Seminar: Technical Writing for the Pharmaceutical, Medical Device and Biotech Industrie...
Joy L. McElroy
Recorded Duration : 180 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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(TMF)- Trial Master File: FDA Expectations from Sponsors and Sites
Carolyn Troiano
Recorded Duration : 60 Minutes
Life Sciences > Clinical | Biotechnology | Laboratory
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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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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Verification and Validation – Product, Process or Equipment and QMS Software
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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3-hr Virtual Seminar: Design Controls for Medical Devices
Susanne Manz
Recorded Duration : 180 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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4 Hour Virtual Seminar on Batch Record Review and Product Release
Danielle DeLucy
Recorded Duration : 360 Minutes
Life Sciences > Pharmaceutical | Biotechnology | Clinical | Laboratory
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in o...
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How to Write SOP’s for Human Error Reduction
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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Customs-Trade Partnership Against Terrorism (C-TPAT) Compliance for Regulated Industries
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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