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John E Lincoln

Principal, J. E. Lincoln and Associates LLC


Good Clinical Practice (GCP) Refresher Training
06 Aug This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln John E Lincoln
$399
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
10 August 2021 Attend this webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications
John E Lincoln John E Lincoln
$249
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
On 25 August 2021 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 John E Lincoln
$399
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
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 John E Lincoln
$199
FDA’s Plan to Modernize the 510(k) Pathway: What Regulatory, Quality and Compliance Professionals Need to Know
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 John E Lincoln
$287
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
MP3 Download Learn the basic overview of the original medical device Quality Management System
John E Lincoln John E Lincoln
$229
FDA CDS Software Regulation:The Latest Guidance on Clinical Decision Support Software
MP3 Download This Webinar will discuss clinical decision support (CDS) software might be regulated as a medical device.
John E Lincoln John E Lincoln
$199
Cybersecurity - US FDA Requirements – New Course !
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 John E Lincoln
$240
FDA’s Plan for Modernizing the 510(k) Pathway
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 John E Lincoln
$179
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
MP3 Download / Online On Demand-Duration 180 Minutes
John E Lincoln John E Lincoln
$399
Cybersecurity, Data Integrity, Part 11, and Required Software Validation
MP3 Download This online training describes FDA Guidances on Cybersecurity and Data Integrity , FDA’s enforcement, Software Validation , CGMPs and Cloud
John E Lincoln John E Lincoln
$399
Project Management for FDA-Regulated Companies
MP3 Download Duration 60 Minutes
John E Lincoln John E Lincoln
$199
FDA’s Latest UDI Labeling Requirements
MP3 Download Duration 60 Minutes
John E Lincoln John E Lincoln
$199
How to Deploy Root Cause & CAPA to Minimize Human Error
MP3 Download Duration 60 Minutes
John E Lincoln John E Lincoln
$287