Category:
Author:

John E Lincoln


The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
June 05 This seminar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR, and DHR. It will consider the European Union's new MDR
John E Lincoln John E Lincoln
$499
Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity
June 07 This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority
John E Lincoln John E Lincoln
$265
US FDA Labeling Requirements for Medical Devices
June 08 In this webinar, including some little known or controlled areas which are subject to regulatory scruinty
John E Lincoln John E Lincoln
$265
The Quality System Regulation (cGMP, 21 CFR 210 & 211 and 820)
July 05 This webinar will examine the 14 key elements of the Medical Device CGMPs, 21 CFR 820, the Quality System Regulation
John E Lincoln John E Lincoln
$249
Inspection and Audit Readiness Training for Medical Device Manufacturers
July 07 This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845)
John E Lincoln John E Lincoln
$699
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Aug 02 This seminar will define what are the US FDA's expectations for proper laboratory / clinical / manufacturing practices, systems, equipment usage
John E Lincoln John E Lincoln
$699
Managing Risks in Combination Products and Drug Delivery Systems
Aug 23 This seminar will provide valuable guidance to regulated companies in the development
John E Lincoln John E Lincoln
$699
The EU Clinical Trial Regulation - EU Filings & Registrations
Sep 12 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$995
Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366
Oct 11 This Seminar will provide valuable guidance to regulated companies in development
John E Lincoln John E Lincoln
$699
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 – Good Clinical Practices (GCP)
John E Lincoln John E Lincoln
$265
Part 11 Data Integrity and Cybersecurity - The Latest Developments
MP3 Download Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures
John E Lincoln John E Lincoln
$399
Blockchain Innovations that Connect and Protect the Supply Chain
MP3 Download This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain
John E Lincoln John E Lincoln
$265
Medical Device Process Validation Training for Professionals
MP3 Download This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971
John E Lincoln John E Lincoln
$229
Part 11 Data Integrity and Cybersecurity – The Latest Developments
MP3 Download The cGMPs have been around for decades. Electronic documentation requirements are newer. Initially there were regulations such as 21 CFR Part 11
John E Lincoln John E Lincoln
$499
Medical Device Change(s) and the 510(k)
MP3 Download This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities
John E Lincoln John E Lincoln
$265
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 and implementation of new Lean Project Management Planning concepts including some Agile principles
John E Lincoln John E Lincoln
$299
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
MP3 Download This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes
John E Lincoln John E Lincoln
$199
Data Integrity -- US FDA Requirements
MP3 Download This webinar will focus on the key issues raised by the FDA, not just for products and their manufacture, but expectations
John E Lincoln John E Lincoln
$199
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
510(k) and PMA Submissions Process
MP3 Download This webinar will detail the 510K and PMA processes as well as the EU directives comparing and contrasting those regulations
John E Lincoln John E Lincoln
$265
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
$199
"Zero Defects" and the cGMPs - Pros and Cons
MP3 Download The last few years have seen several major "names" in drugs and devices stumble over quality and cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution
John E Lincoln John E Lincoln
$199
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
Good Clinical Practice (ICH GCP) Course : Core Requirements, Expectations and Challenges
MP3 Download This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln John E Lincoln
$595
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
MP3 Download 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
$499
The Validation Master Plan - The Unwritten Requirements
MP3 Download This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S
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
$249
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
$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
Verification and Validation - Product, Equipment / Process, Software, QMS+
MP3 Download This seminar 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
$1,295
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
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