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John E Lincoln


Courses

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Jan 22-23 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
Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) – A Technical Documentation Training
Feb 03 This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln John E Lincoln
$595
Master Validation Plan - The Unwritten Requirements
Feb 19 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
$495
ChatGPT / AI for Project Management for FDA-Regulated Companies
Feb 26 This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance
John E Lincoln John E Lincoln
$299
Verification and Validation - Product, Equipment/Process, Software and QMS
Feb 25-26 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
Risk Management for AI in Medical Devices: Insights from FDA's Lifecycle Management Draft Guidance
Mar 10 This webinar will discuss information specific to devices that include artificial intelligence algorithms that make real-world modifications that the agency might require for premarket review
John E Lincoln John E Lincoln
$299
The EU Clinical Trial Regulation - EU Filings & Registrations
Mar 24 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$595
AI in Drug Development
Apr 02 This seminar will evaluate these stated FDA policy shifts as it applies to drug discovery and development.
John E Lincoln John E Lincoln
$299
Human Error Prevention (HEP) - Risk Factors and Strategies
MP3 Download This presentation focuses on the use of HEP, HRA and HEART tools to add additional review areas to Risk Management and Human Factors Analysis to effect beneficial
John E Lincoln John E Lincoln
$595
Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions
MP3 Download This webinar will discuss current US Federal law on the 510(k), IDE, DeNovo, and PMA and associated requirements for getting a new or substantially changed medical device through the US FDA review process and to market in the USA.
John E Lincoln John E Lincoln
$695
GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials
MP3 Download This webinar will provide test scripts and rationale for a "model" for internal /self-audits.
John E Lincoln John E Lincoln
$299
Preparing the CMC Section for NDAs/INDs/CTDs
MP3 Download This webinar will discuss current US Federal law on NDAs and INDs and CMC and other associated requirements for getting a new drug through the US FDA review process and to market in the USA.
John E Lincoln John E Lincoln
$299
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
$199
Software Verification and Validation - The 10 Must Have Documents
MP3 download 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
Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies
MP3 Download This webinar will define what are the US FDA's expectation for proper laboratory practices, systems, equipment usage, and documentation / record-keeping
John E Lincoln John E Lincoln
$299
US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation
MP3 Download This seminar 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
$1,495
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
$399
CRO, CDMO and Non-Clinical Vendor Management Fundamentals
MP3 Download The medical products supply chain is a complex global enterprise. Regulatory agencies are increasingly recognizing that fact and incorporating
John E Lincoln John E Lincoln
$299
Device and Software Changes and the 510(k)
MP 3 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
$199
Drug and Device Production and Process Control (P&PC) / SPC / 6 Sigma Tools
MP3 Download This webinar will define what are the US FDA's expectation for Production and Process Control / Product Realization, the use of statistical techniques, 6 sigma, SPC, for establishing, controlling
John E Lincoln John E Lincoln
$199
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
Drug, Device and Combination Product Development
MP3 Download 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
Introduction to Medical Combination Products
MP3 Download This webinar will provide valuable assistance to all regulated companies in evaluating their existing product development
John E Lincoln John E Lincoln
$199
Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management
MP3 Download This webinar will discuss the ISO-defined and classified cleanroom (especially US FDA-regulated) to include its systems for establishing
John E Lincoln John E Lincoln
$399
Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance
MP3 Download 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
AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework
MP3 Download 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
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
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
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