JOHN E. LINCOLN - Eventura

Effective Design Control (21 CFR Part 820.30)

Duration: 90 Minutes

JOHN E. LINCOLN

3-HOUR VIRTUAL SEMINAR ON 510(K)'S, PMA'S, IDE'S AND DENOVO'S

Duration: 3 Hour

JOHN E. LINCOLN

Statistical Process Control (SPC) and Control Charts - In Accordance with Latest FDA Expectations

Duration: 90 Minutes

JOHN E. LINCOLN

3-Hour Virtual Seminar on Part 11 Data Integrity and Cybersecurity – The Latest Developments

Duration: 3 Hour

JOHN E. LINCOLN

FDA’s 21 CFR Part 11 Add-on Inspections

Duration: 90 Minutes

JOHN E. LINCOLN

GCP/GLP/GMP : Comparison And Understanding of the FDA's 3 Major Regulations

Duration: 90 Minutes

JOHN E. LINCOLN

Human Factors Engineering to Satisfy the New IEC 62366-1, -2

Duration: 90 Minutes

JOHN E. LINCOLN

Cybersecurity – FDA Requirements Masterclass

Duration: 90 Minutes

JOHN E. LINCOLN

3-Hour Virtual Seminar on Master Validation Plan – The Unwritten Requirements

Duration: 3 Hour

JOHN E. LINCOLN

U.S. FDA’s Strategic Priorities – 2016 and Beyond

Duration: 90 Minutes

JOHN E. LINCOLN

FDA’s New Draft Guidance on Data Integrity for cGMP Compliance

Duration: 90 Minutes

JOHN E. LINCOLN

Clinical IT Inspection Readiness

Duration: 90 Minutes

JOHN E. LINCOLN

The FDA’s Guidance on Wireless Devices

Duration: 90 Minutes

JOHN E. LINCOLN

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier

Duration: 90 Minutes

JOHN E. LINCOLN

Drafting a Software V&V Documentation Package and Protocol

Duration: 90 Minutes

JOHN E. LINCOLN

Failure Investigation, Root Cause Analysis – Tools and Techniques

Duration: 90 Minutes

JOHN E. LINCOLN

Process Verification and Validation

Duration: 90 Minutes

JOHN E. LINCOLN

The New Usability Engineering Standard in IEC 62366-1:2015- Application and IEC/TR 62366-2:2016

Duration: 90 Minutes

JOHN E. LINCOLN

IQ, OQ, PQ in the Verification and Validation Process

Duration: 90 Minutes

JOHN E. LINCOLN

The Master Validation Plan – The Unwritten Requirements

Duration: 90 Minutes

JOHN E. LINCOLN

U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process

Duration: 90 Minutes

JOHN E. LINCOLN

Additive / 3D Printing Manufacturing and Its Regulatory Issues

Duration: 90 Minutes

JOHN E. LINCOLN

EO Sterilization Validation / Revalidation per ISO 11135

Duration: 90 Minutes

JOHN E. LINCOLN

3-Hour Virtual Seminar On US FDA Cybersecurity Requirements - The Latest Developments

Duration: 3 Hour

JOHN E. LINCOLN

Process Verification And Validation - Principles And Protocols

Duration: 90 Minutes

JOHN E. LINCOLN

EU's New Regulation 536/2014 On Clinical Trials - Insights Into Effective Clinical Trials

Duration: 90 Minutes

JOHN E. LINCOLN

The US FDA QMSR Transition - 21 CFR 820 And ISO 13485

Duration: 90 Minutes

JOHN E. LINCOLN

3-Hour Virtual Seminar On U.S. FDA And EU Medical Device Directive Requirements For DHFS, DMRS, DHRS, And TF/DDS

Duration: 3 Hour

JOHN E. LINCOLN

The eSTAR Submission Program For 510(K)S, IDES, DE NOVOS, PMAS, And Q-Submissions

Duration: 90 Minutes

JOHN E. LINCOLN

GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers

6-Hour Seminar Completed | Recording and Pre-Registration Available

JOHN E. LINCOLN

How To Best Document The Clinical Evaluation Report (CER) For The CE Mark

Duration: 90 Minutes

JOHN E. LINCOLN

US FDA'S AI Framework For Medical Devices

Duration: 90 Minutes

JOHN E. LINCOLN

Verification and Validation - Product, Equipment / Process, Software and QMS

September 16 - 17, 2024 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM

JOHN E. LINCOLN

Preparing a 510(k) Premarket Notification

Duration: 90 Minutes

JOHN E. LINCOLN

Laboratory Developed Tests (LDT) - The Impact of the Final Rule

Duration: 90 Minutes

JOHN E. LINCOLN

Failure Investigation and Root Cause Analysis - Tools and Techniques

Duration: 90 Minutes

JOHN E. LINCOLN

510(k) Modernization, Breakthrough Device, and Safer Technologies Programs (STeP)

Duration: 90 Minutes

JOHN E. LINCOLN

FDA Medical Device Changes And The 510(K)

Duration: 90 Minutes

JOHN E. LINCOLN

Supplier Management with the new EU MDR 745/2017

Duration: 90 Minutes

JOHN E. LINCOLN

Avoid Warning Letters in View of the U.S. FDA's Stated Goal

Duration: 90 Minutes

JOHN E. LINCOLN

Internal and External / Supplier Audits Essentials

March 24 - 25, 2025 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM

JOHN E. LINCOLN

The DHF, Technical Documentation - Similarities, Differences and the Future

May 13 - 14, 2025 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM

JOHN E. LINCOLN

Developing Effective Post Market Surveillance and Complaint Handling Requirements (Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls)

November 17 - 18, 2025 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM

JOHN E. LINCOLN

The Latest FDA Q-Submission Final Guidance

Duration: 90 Minutes

JOHN E. LINCOLN

The FDA QMSR: Transition, Documentation, and cGMP Audits Preparation based on New Regulations

November 17 - 18, 2025 | US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM

JOHN E. LINCOLN

Risk-Driven Production and Process Validation Systems Across FDA and EU (Merging QMSR and EU Annex 15)

June 22 - 23, 2026 | US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM

JOHN E. LINCOLN