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Author:
John E Lincoln
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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
Eleonora Babayants
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
Find a product
John E Lincoln
Device Changes, FDA Changes, and the 510(k)
Available until
June 15 In this webinar you will learn What approaches are required for product changes; for process changes
John E Lincoln
%
COMPLETE
$199
The Most Common Problems in FDA Software Validation & Verification
Available until
July 06 This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln
%
COMPLETE
$199
Project Management for FDA-Regulated Companies
Available until
Aug 16 This webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project Management Planning concepts including some Agile principles
John E Lincoln
%
COMPLETE
$199
"Zero Defects" and the cGMPs - Pros and Cons
Available until
Sep 07 The last few years have seen several major "names" in drugs and devices stumble over quality and cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution
John E Lincoln
%
COMPLETE
$199
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
Available until
MP3 Download 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
Good Clinical Practice (ICH GCP) Course : Core Requirements, Expectations and Challenges
Available until
MP3 Download This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln
%
COMPLETE
$595
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
Available until
MP3 Download This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3
John E Lincoln
%
COMPLETE
$499
The Validation Master Plan - The Unwritten Requirements
Available until
MP3 Download This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S
John E Lincoln
%
COMPLETE
$199
Data Integrity -- US FDA Requirements
Available until
MP3 Download This webinar will focus on the key issues raised by the FDA, not just for products and their manufacture, but expectations
John E Lincoln
%
COMPLETE
$199
Cybersecurity - US FDA Requirements – New Course !
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
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
Verification and Validation - Product, Equipment / Process, Software, QMS+
Available until
MP3 Download This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s).
John E Lincoln
%
COMPLETE
$1,295
FDA’s Plan to Modernize the 510(k) Pathway: What Regulatory, Quality and Compliance Professionals Need to Know
Available until
MP3 Download This webinar will discuss the 510(k) framework to reflect advances in device technology, safety and capabilities, making it harder to obtain
John E Lincoln
%
COMPLETE
$287
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
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
Available until
MP3 Download Learn the basic overview of the original medical device Quality Management System
John E Lincoln
%
COMPLETE
$229
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