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John E Lincoln


Courses

Master Validation Plan - The Unwritten Requirements
July 09 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
Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validation
July 09 Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al
John E Lincoln John E Lincoln
$199
AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework
Jul 30 The use of Generitive AI in the Drug discovery and Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals - their risk-based framework.
John E Lincoln John E Lincoln
$199
Software Verification and Validation - The 10 Must Have Documents
Aug 05 The tougher FDA expects a company to develop and run a formal software V&V plan . The model presented here satisfies their requirements for all software/firmware/PLC V&V.
John E Lincoln John E Lincoln
$199
The EU Clinical Trial Regulation - EU Filings & Registrations
Aug 20 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$995
Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance
20 Aug This webinar will cover the FDA’s total product life cycle approach and FDA’s roles and responsibilities in regulating medical devices throughout their lifecycle. The US FDA has long promoted a Risk-Based Total Product Life Cycle (TPLC)
John E Lincoln John E Lincoln
$199
Drug, Device and Combination Product Development
Aug 25 Combination products are subject to a combination of CGMPs to form an "Operating System". This greatly increases compliance to the Combo Products CFMPs, 21 CFR 4. And recent problems have compounded supply chain issues.
John E Lincoln John E Lincoln
$199
Verification and Validation - Product, Equipment/Process, Software and QMS
Sep 11-12 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
$1,295
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Sep 16-17 This seminar 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
Changes to 21 CFR 820 - Device QSR to QMSR - Due February 02, 2026
MP3 Download This webinar will discuss what the new QMSR will require, by including a discussion of the Final Rule and its Preamble
John E Lincoln John E Lincoln
$199
Cybersecurity - The Latest US FDA Requirements
MP3 Download 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
$299
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
$199
Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) – A Technical Documentation Training
Jun 26 This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln John E Lincoln
$595
Technical Writing for Technical Personnel (In a Regulated Industry)
MP3 Download Technical writing is a specialized form of writing often used by an organization's SME"s
John E Lincoln John E Lincoln
$199
The Quality System Regulation (cGMP 820) and the new QMSR
MP3 Download This webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference
John E Lincoln John E Lincoln
$199
SPC (Statistical Process Control) / Control Charts
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)
John E Lincoln John E Lincoln
$199
Generative AI in Drug Discovery
MP3 Download The use of Generitive AI in the Drug Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals.
John E Lincoln John E Lincoln
$749
Device Changes and the 510(k) -- Device Hardware and Software Requirements
MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k)
John E Lincoln John E Lincoln
$189
NEW: " New Predetermined Change Control Plans (PCCP) for Medical Devices
MP3 Download This webinar will discuss the FDA's draft guidance recommendations for PCCPs as part of 510(k) or PMA submissions where future device changes are basically known
John E Lincoln John E Lincoln
$189
Inspection and Audit Readiness Training for Medical Device Manufacturers
MP3 Download This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections
John E Lincoln John E Lincoln
$545
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
Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity
MP3 Download This has resulted in the FDA focusing on the subset of software functions dealing
John E Lincoln John E Lincoln
$199
Good Clinical Practices and Good Laboratory Practices
MP3 Download This webinar will examine the basic requirements of the GLPs and GCP’s and related / supporting requirements
John E Lincoln John E Lincoln
$199
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
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