JOHN E. LINCOLN - Eventura

Effective Design Control (21 CFR Part 820.30)

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 3 Hour

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

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 3 Hour

FDA’s 21 CFR Part 11 Add-on Inspections

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

Cybersecurity – FDA Requirements Masterclass

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 3 Hour

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

JOHN E. LINCOLN

Duration: 90 Minutes

FDA’s New Draft Guidance on Data Integrity for cGMP Compliance

JOHN E. LINCOLN

Duration: 90 Minutes

Clinical IT Inspection Readiness

JOHN E. LINCOLN

Duration: 90 Minutes

The FDA’s Guidance on Wireless Devices

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

Drafting a Software V&V Documentation Package and Protocol

JOHN E. LINCOLN

Duration: 90 Minutes

Failure Investigation, Root Cause Analysis – Tools and Techniques

JOHN E. LINCOLN

Duration: 90 Minutes

Process Verification and Validation

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

IQ, OQ, PQ in the Verification and Validation Process

JOHN E. LINCOLN

Duration: 90 Minutes

The Master Validation Plan – The Unwritten Requirements

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

Additive / 3D Printing Manufacturing and Its Regulatory Issues

JOHN E. LINCOLN

Duration: 90 Minutes

EO Sterilization Validation / Revalidation per ISO 11135

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 3 Hour

Process Verification And Validation - Principles And Protocols

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers

JOHN E. LINCOLN

2-Day Seminar Completed | Recording and Pre-Registration Available

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

JOHN E. LINCOLN

Duration: 3 Hour

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

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

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

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

JOHN E. LINCOLN

Duration: 90 Minutes

US FDA'S AI Framework For Medical Devices

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

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

Preparing a 510(k) Premarket Notification

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

December 10 - 11, 2024 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM

Failure Investigation and Root Cause Analysis - Tools and Techniques

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

FDA Medical Device Changes And The 510(K)

JOHN E. LINCOLN

Duration: 90 Minutes

Supplier Management with the new EU MDR 745/2017

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

Internal and External / Supplier Audits Essentials

JOHN E. LINCOLN

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

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

JOHN E. LINCOLN

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