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John E Lincoln
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Barry A. Friedman
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Carolyn Troiano
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Charity Ogunsanya
Charles H. Paul
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Danielle DeLucy
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David L. Chesney
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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
Steve Jolley
Steven Laurenz
Steven Wachs
Susanne Manz
Theodore Sand
Tim Fischer
Todd Graham
Travis Austin MacKay
Trisha Paul
William Mack Copeland
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John E Lincoln
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
Available until
Apr 30 This Webinar will discuss the latest U.S. FDA and European Union requirements on Design History File, and Technical File/Design Dossier
John E Lincoln
%
COMPLETE
$199
Avoid Warning Letters in View of the U.S. FDA's Stated Goal
Available until
May 03 FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
John E Lincoln
%
COMPLETE
$199
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Available until
May 29 Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations
John E Lincoln
%
COMPLETE
$199
Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements
Available until
Jun 05 In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions
John E Lincoln
%
COMPLETE
$199
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Available until
June 05-06 This webinar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles
John E Lincoln
%
COMPLETE
$1,895
The Most Common Problems in FDA Software Validation & Verification
Available until
Jul 02 This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln
%
COMPLETE
$249
The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
Available until
Aug 02 This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln
%
COMPLETE
$499
Verification and Validation - Product, Equipment/Process, Software and QMS
Available until
July 16-17 This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation
John E Lincoln
%
COMPLETE
$1,295
Device Changes, FDA Changes, and the 510(k)
Available until
MP3 Download In this webinar you will learn What approaches are required for product changes; for process changes
John E Lincoln
%
COMPLETE
$199
The EU Clinical Trial Regulation - EU Filings & Registrations
Available until
Sep 11 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln
%
COMPLETE
$895
Master Validation Plan - The Unwritten Requirements
Available until
MP3 Download What is the FDA definition of "risk based" and how is it documented in the V&V test report. Additional recommended supporting systems / documentation
John E Lincoln
%
COMPLETE
$399
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Available until
MP3 Download This web presentation presents an overview of FDA’s 3 major regulations
John E Lincoln
%
COMPLETE
$199
Cybersecurity - The Latest US FDA Requirements
Available until
MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production by update, the CAPA system, among others
John E Lincoln
%
COMPLETE
$199
Project Management for FDA-Regulated Companies in the Postpandemic World: Are You Ready for New Approaches and Methods?
Available until
MP3 Download This webinar will provide valuable guidance to regulated companies in development
John E Lincoln
%
COMPLETE
$249
Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
Available until
MP3 Download This Webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning.
John E Lincoln
%
COMPLETE
$199
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Available until
MP3 Download Attend this webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications
John E Lincoln
%
COMPLETE
$249
FDA CDS Software Regulation:The Latest Guidance on Clinical Decision Support Software
Available until
MP3 Download This Webinar will discuss clinical decision support (CDS) software might be regulated as a medical device.
John E Lincoln
%
COMPLETE
$199
FDA’s Plan for Modernizing the 510(k) Pathway
Available until
MP3 Download This FDA Training online will explain Basic of US FDA’s Expectations for the 510(k), The Medical Device Safety Action Plan and 510(k)
John E Lincoln
%
COMPLETE
$179
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
Available until
MP3 Download / Online On Demand-Duration 180 Minutes
John E Lincoln
%
COMPLETE
$399
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
FDA’s Latest UDI Labeling Requirements
Available until
MP3 Download Duration 60 Minutes
John E Lincoln
%
COMPLETE
$199
How to Deploy Root Cause & CAPA to Minimize Human Error
Available until
MP3 Download Duration 60 Minutes
John E Lincoln
%
COMPLETE
$287