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John E Lincoln


Courses

Master Validation Plan - The Unwritten Requirements
Nov 25 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 John E Lincoln
$499
Cybersecurity - The Latest US FDA Requirements
25 Nov 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 John E Lincoln
$349
The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
Nov 26 This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln John E Lincoln
$795
The EU Clinical Trial Regulation - EU Filings & Registrations
Dec 05 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$895
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Dec 11-12 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 John E Lincoln
$1,895
Verification and Validation - Product, Equipment/Process, Software and QMS
MP3 Download This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation
John E Lincoln John E Lincoln
$1,495
Understanding How Quality Management Works
MP3 Download This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how most QMS' requirements build upon that foundation
John E Lincoln John E Lincoln
$189
P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3
MP3 Download This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs
John E Lincoln John E Lincoln
$189
QMS 101: Quality Management System Guide
MP3 Download This webinar discusses the key parts of ISO 9001, especially how it applies to manufacturing. However, its principles can, and are, used in many different business activities
John E Lincoln John E Lincoln
$189
Consumer Food and Health Attitudes
MP3 Download This webinar is based on information from the public domain, personal interviews, internet and social media discussions, news articles, and similar resources
John E Lincoln John E Lincoln
$189
Device Changes, FDA Changes, and the 510(k)
MP3 Download In this webinar you will learn What approaches are required for product changes; for process changes
John E Lincoln John E Lincoln
$189
Quality Management 101: Enterprise Maintenance Professional's Guide
MP3 Download This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how a company's preventative and predictive maintenance programs can be enhances by the QMA requirements
John E Lincoln John E Lincoln
$189
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3
MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development
John E Lincoln John E Lincoln
$189
The Most Common Problems in FDA Software Validation & Verification
MP3 Download This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln John E Lincoln
$189
Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements
MP3 Download In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions
John E Lincoln John E Lincoln
$198
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
MP3 Download Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations
John E Lincoln John E Lincoln
$199
Avoid Warning Letters in View of the U.S. FDA's Stated Goal
MP3 Download FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
John E Lincoln John E Lincoln
$199
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
MP3 Download This web presentation presents an overview of FDA’s 3 major regulations
John E Lincoln John E Lincoln
$199
Project Management for FDA-Regulated Companies in the Postpandemic World: Are You Ready for New Approaches and Methods?
MP3 Download This webinar will provide valuable guidance to regulated companies in development
John E Lincoln John E Lincoln
$249
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
Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
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 John E Lincoln
$199
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
MP3 Download 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
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
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
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