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Alan Golden
Amanda McFarland
Andrew Campbell
Angela Bazigos
Barry A. Friedman
Ben Marandi
Carl Patterson
Carolyn Troiano
Casper (Cap) Uldriks
Charity Ogunsanya
Charles H. Paul
Cynthia Brysch
Danielle DeLucy
David Jones
David L. Chesney
David Nettleton
David R. Dills
David W. Husman
Dr. Afsaneh Motamed Khorasani
Dr. John M. Ryans
Dr. Michael Abitz
Dr. Stefano Persiani
Edwin Waldbusser
Elaine Eisenbeisz
Frank Stein
Ginette Collazo
Graeme Ladds
Jan Seal
Jeff Kasoff
Jim Sheldon-Dean
Joanna Brougher
John C. Fetzer
John E Lincoln
John G. Lanese
Jose Mora
Jose Mora
Joy L. McElroy
Karl M. Nobert
Kelly Eisenhardt
Kelly Thomas
Lisa Hardwick Thompson
Mark Brengelman
Mark Hughes
Mark Powell
Martin K. Behr
Meena Chettiar
Michael Esposito
Michael Ramcharan
Nancy Knettell
Nissan Cohen
Paolo Giacomoni
Paul Larocque
Peggy J. Berry
Peter Reijntjes
Rita Hoffman
Rob MacCuspie
Roger Cowan
Ron Snee
Speaker
Speaker for Biotechnology
Steven Laurenz
Susanne Manz
Theodore Sand
Tim Fischer
Todd Graham
Travis Austin MacKay
Trisha Paul
William Mack Copeland
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Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?
Available until
MP3 Download This webinar will help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas
Susanne Manz
%
COMPLETE
$389
Sunscreens: Their Importance and US Regulations
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MP3 Download Duration 90 Minutes
Paolo Giacomoni
%
COMPLETE
$199
Overview of Pharmacovigilance Under COVID-19
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MP3 Download This Pharmaceutical training online aims to demonstrate what the new guidances allow in terms of pharmacovigilance activities that can be relaxed
Graeme Ladds
%
COMPLETE
$199
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
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MP3 Download / Online On Demand-Duration 180 Minutes
John E Lincoln
%
COMPLETE
$399
Learn the latest Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar
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MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
A Culture of Quality is a Competitive Advantage
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MP3 Download This webinar will cover FDA and NB expectations for Quality Systems , Best Practices and How culture can impact quality and compliance risk in 2021
Susanne Manz
%
COMPLETE
$199
Understanding the Design Verification and Validation Requirements for Medical Devices
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MP3 Download Duration 60 Minutes
Meena Chettiar
%
COMPLETE
$199
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
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MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
Managing Compliance during the Pandemic
Available until
MP3 Download Duration 60 Minutes
Danielle DeLucy
%
COMPLETE
$199
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
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MP3 Download This webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records
Carolyn Troiano
%
COMPLETE
$199
4-Hour Virtual Seminar - Batch Record Review and Product Release
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MP3 Download Duration 240 Minutes
Danielle DeLucy
%
COMPLETE
$499
NEW FDA Proposed FSMA Rule on Food Traceability During COVID19 – New Course
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MP3 Download Duration 60 Minutes
Dr. John M. Ryans
%
COMPLETE
$199
Properly Managing CAPA Programs for Successful Implementation
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MP3 Download Duration 90 Minutes
Danielle DeLucy
%
COMPLETE
$199
Why people make mistakes. Understanding Human error
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MP3 Download Duration 90 Minutes
Ginette Collazo
%
COMPLETE
$199
Clinical Data Management Training
Available until
MP3 Download Duration 2 Day
Elaine Eisenbeisz
%
COMPLETE
$1,699
Rouge Monitoring - The usage of science-based online instrumentation to determine derouging and pas
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MP3 Download Duration 60 Minutes
Nissan Cohen
%
COMPLETE
$199
Webinar FDA’s Regulatory Management of Your Cybersecurity Threats
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MP3 Download -Duration 60 Minutes
Casper (Cap) Uldriks
%
COMPLETE
$199
Masterclass: 4 Keys to Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations
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MP3 Download Duration 120 Minutes
John G. Lanese
%
COMPLETE
$499
FDA’s Regulation Human Cellular Biologics including Preclinical and First-In-Human Considerations
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MP3 Download Duration 90 Minutes
Karl M. Nobert
%
COMPLETE
$199
Learn the latest webinar Software Validation Utilizing Principles of Lean Documents and Lean Configuration
Available until
24-Feb,2021 at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Jose Mora
%
COMPLETE
$199
Cybersecurity, Data Integrity, Part 11, and Required Software Validation
Available until
MP3 Download This online training describes FDA Guidances on Cybersecurity and Data Integrity , FDA’s enforcement, Software Validation , CGMPs and Cloud
John E Lincoln
%
COMPLETE
$399
Understanding the Design Verification and Validation Requirements for Medical Devices
Available until
MP3 Download Duration 60 Minutes
Meena Chettiar
%
COMPLETE
$199
Managing Your FDA Inspection’s 483 Observations
Available until
MP3 Download Duration 60 Minutes
Casper (Cap) Uldriks
%
COMPLETE
$199
Secrets for Writing Excellent SOPs for Medical Device QMS
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MP3 Download Duration 90 Minutes
Susanne Manz
%
COMPLETE
$199
Patient Access of PHI and Communications – How to Use Plain Texting and E-mail under HIPAA
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MP3 Download / Online On Demand-Duration 90 Minutes
Jim Sheldon-Dean
%
COMPLETE
$199
Best Practices To Help You Pass An FDA Computer System Validation Audit
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MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
Detailed Investigations: How to avoid an observation
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MP3 Download Duration 60 Minutes
Carl Patterson
%
COMPLETE
$199
How to Implement a Compliant Training Program and Reduce Human Error
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MP3 Download Duration 90 Minutes
Ginette Collazo
%
COMPLETE
$199
What You Need to Know IEC 62304 and Demystifying Software Validation using the Principles of LDLC
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MP3 Download Duration 180 Minutes
Jose Mora
%
COMPLETE
$299
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
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MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$199
Understanding Quality Control Testing
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MP3 Download Duration 60 Minutes
Carl Patterson
%
COMPLETE
$199
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall
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MP3 Download Duration 90 Minutes
Carolyn Troiano
%
COMPLETE
$299
Annex 1 and its Comparison to Critical Utilities Compendial mandates: What does it all imply to the
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MP3 Download Duration 60 Minutes
Nissan Cohen
%
COMPLETE
$199
Data Integrity Practices for the Laboratory and Beyond
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MP3 Download -Duration 90 Minutes
Kelly Thomas
%
COMPLETE
$199
Technical Writing for the Pharmaceutical Industry
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MP3 Download Duration 60 Minutes
Carl Patterson
%
COMPLETE
$199
Understanding the FDA: How to avoid the most recent observations - Annual 4-Part Live Training Annual
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MP3 Download Annual 4-Part
Carl Patterson
%
COMPLETE
$599
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