Category:
Author:

John E Lincoln

Principal, J. E. Lincoln and Associates LLC


DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
24 May 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 CDS Software Regulation:The Latest Guidance on Clinical Decision Support Software
04 June This Webinar will discuss clinical decision support (CDS) software might be regulated as a medical device.
John E Lincoln John E Lincoln
$199
Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
07 July This webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s)
John E Lincoln John E Lincoln
$199
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
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
On Demand Webinar Duration 60 minutes
John E Lincoln John E Lincoln
$289