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Medical device Training (104)
FDA Regulatory Compliance Training (326)
Pharma Courses & Pharmaceutical Training (282)
Biotechnology Online Courses and Training (254)
Clinical trial Training (11)
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Virtual Seminars (88)
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Europe Seminars (31)
USA Seminars (56)
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
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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Find a product
John E Lincoln
Project Management for FDA-Regulated Companies in the Postpandemic World: Are You Ready for New Approaches and Methods?
Available until
Dec 06 This webinar will provide valuable guidance to regulated companies in development
John E Lincoln
%
COMPLETE
$249
The EU Clinical Trial Regulation - EU Filings & Registrations
Available until
Dec 14 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln
%
COMPLETE
$895
Verification and Validation - Product, Equipment/Process, Software and QMS
Available until
Jan 24-25 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
510(k) and PMA Submissions Process
Available until
Jan 25 This webinar will detail the 510K and PMA processes as well as the EU directives comparing and contrasting those regulations
John E Lincoln
%
COMPLETE
$249
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Available until
Feb 06 This web presentation presents an overview of FDA’s 3 major regulations
John E Lincoln
%
COMPLETE
$287
US FDA Labeling Requirements for Medical Devices
Available until
Mar 06 In this webinar, including some little known or controlled areas which are subject
John E Lincoln
%
COMPLETE
$269
Establish a Compliant Medical Device Post Market Surveillance and Complaint Handling System
Available until
MP3 Download 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 Quality System Regulation (cGMP, 21 CFR 210 & 211 and 820)
Available until
MP3 Download This webinar will examine the 14 key elements of the Medical Device CGMPs,
John E Lincoln
%
COMPLETE
$269
Medical Device Process Validation Training for Professionals
Available until
MP3 Download This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP
John E Lincoln
%
COMPLETE
$269
The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
Available until
MP3 Download This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln
%
COMPLETE
$599
Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366
Available until
MP3 Download This Seminar will provide valuable guidance to regulated companies in development
John E Lincoln
%
COMPLETE
$1,899
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
John E Lincoln
%
COMPLETE
$287
Managing Risks in Combination Products and Drug Delivery Systems
Available until
MP3 Download This seminar will provide valuable guidance to regulated companies in the development
John E Lincoln
%
COMPLETE
$699
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Available until
MP3 Download This seminar will define what are the US FDA's expectations for proper laboratory / clinical / manufacturing practices, systems
John E Lincoln
%
COMPLETE
$699
Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity
Available until
MP3 Download This has resulted in the FDA focusing on the subset of software functions dealing
John E Lincoln
%
COMPLETE
$265
Part 11 Data Integrity and Cybersecurity - The Latest Developments
Available until
MP3 Download Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures
John E Lincoln
%
COMPLETE
$399
Inspection and Audit Readiness Training for Medical Device Manufacturers
Available until
July 07 This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845)
John E Lincoln
%
COMPLETE
$699
Blockchain Innovations that Connect and Protect the Supply Chain
Available until
MP3 Download This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain
John E Lincoln
%
COMPLETE
$265
Part 11 Data Integrity and Cybersecurity – The Latest Developments
Available until
MP3 Download The cGMPs have been around for decades. Electronic documentation requirements are newer. Initially there were regulations such as 21 CFR Part 11
John E Lincoln
%
COMPLETE
$499
Medical Device Change(s) and the 510(k)
Available until
MP3 Download This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities
John E Lincoln
%
COMPLETE
$265
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
Available until
MP3 Download This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes
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
The Most Common Problems in FDA Software Validation & Verification
Available until
MP3 Download This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln
%
COMPLETE
$199
"Zero Defects" and the cGMPs - Pros and Cons
Available until
MP3 Download 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
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
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
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
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
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
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
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
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