Medical Device - Eventura

The Latest FDA Q-Submission Final Guidance

Duration: 90 Minutes

JOHN E. LINCOLN

The Supervisor's Guide to a Human Error-Free Environment

Duration: 90 Minutes

Dr. Ginette Collazo

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

Duration: 90 Minutes

JOHN E. LINCOLN

Project Management for Non-Project Managers Series - Role of Project Management in Quality Planning Throughout the Medical Device Project Lifecycle

Duration: 2 Hour

CHARLES H. PAUL

Regulatory Audit Preparedness

Duration: 60 Minutes

Supplier Management with the new EU MDR 745/2017

Duration: 90 Minutes

JOHN E. LINCOLN

GLP Data Integrity - Ensuring Accurate Reliable Results

Duration: 90 Minutes

CHARLES H. PAUL

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

Duration: 90 Minutes

JOHN E. LINCOLN

How to Ace an FDA Meeting - Preparation and Conduct

Duration: 90 Minutes

CHARLES H. PAUL

FDA Warning Letter - Consent Decree Software Validation

Duration: 90 Minutes

MEREDITH CRABTREE

Failure Investigation and Root Cause Analysis - Tools and Techniques

Duration: 90 Minutes

JOHN E. LINCOLN

Design Verification and Validation

Duration: 90 Minutes

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

Duration: 90 Minutes

JOHN E. LINCOLN

Cybersecurity in Medical Devices Latest Guidance: Quality System Considerations and Content of Premarket Submissions

Duration: 90 Minutes

CAROLYN TROIANO

Preparing a 510(k) Premarket Notification

Duration: 90 Minutes

JOHN E. LINCOLN

Conducting Successful Complaint Investigations In Regulated Industries

Duration: 90 Minutes

MEREDITH CRABTREE

FDA Labeling and UDI Essentials for Medical Products

Duration: 90 Minutes

US FDA'S AI Framework For Medical Devices

Duration: 90 Minutes

JOHN E. LINCOLN

3-Hour Virtual Seminar On Digital Validation Demystified - GAMP® 5 2.0 And CSA Integration

Duration: 3 Hour

CAROLYN TROIANO

Master The Vendor Auditing Of Your Computer Systems Regulated By FDA

Duration: 90 Minutes

CAROLYN TROIANO

Writing Investigations That Meet Regulatory Requirements

Duration: 90 Minutes

CHARLES H. PAUL

Design Planning, Design History Files and Design Reviews

Duration: 60 Minutes

Validation Of Artificial Intelligence (AI), Machine Learning (ML), And Other Superintelligence Based GxP Systems

Duration: 90 Minutes

CAROLYN TROIANO

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

Duration: 90 Minutes

JOHN E. LINCOLN

Good Clinical Practices (GCP) Audit And Inspection Readiness

Duration: 90 Minutes

CHARLES H. PAUL

Designing Effective And Efficient Extractables Or Leachables Studies

Duration: 90 Minutes

The Art Of Technology Transfer In Drug Development: Developing And Building A Framework Of Success

Duration: 90 Minutes

SCOTT R. THATCHER

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

Duration: 90 Minutes

JOHN E. LINCOLN

Risk-Based Excel Spreadsheet Validation

Duration: 90 Minutes

CAROLYN TROIANO

FDA Regulation For Over-The-Counter (OTC) Drug Products

Duration: 90 Minutes

MEREDITH CRABTREE

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

Preventive Maintenance And Calibrations - Regulatory Expectations And Best Practices

Duration: 90 Minutes

MEREDITH CRABTREE

Using Audit Trails To Support Part 11 Data Integrity Compliance

Duration: 90 Minutes

CAROLYN TROIANO

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

Duration: 90 Minutes

JOHN E. LINCOLN

Design Control For Medical Devices And Combination Products

Duration: 60 Minutes

Clinical Trial Master File (TMF) And Electronic Trial Master File (ETMF)

Duration: 90 Minutes

CAROLYN TROIANO

Drug Master Files (DMFS) - Understanding And Meeting Your Global Regulatory And Processing Responsibilities

Duration: 90 Minutes

CHARLES H. PAUL

The FDA Inspection From SOP To 483

Duration: 90 Minutes

IQ, OQ And PQ Quality Protocols - Current Regulatory Requirements

Duration: 90 Minutes

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

Duration: 90 Minutes

JOHN E. LINCOLN

Production And Process Controls For Medical Devices

Duration: 90 Minutes

Establishing FDA-Compliant Product Stability Testing Program

Duration: 60 Minutes

Moving From CSV To CSA

Duration: 60 Minutes

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

Duration: 3 Hour

JOHN E. LINCOLN

Data Integrity And Human Error

Duration: 90 Minutes

Dr. Ginette Collazo

FDA vs EU Inspections - Differences And Similarities - How To Get Prepared

Duration: 90 Minutes

CHARLES H. PAUL

Risk Management For ML Medical Devices Following AAMI/ BSI TR 34971 And ISO 14971

Duration: 60 Minutes

Edwin Waldbusser

3-Hour Virtual Seminar On Root Cause Analysis, CAPA And Effectiveness Checks

Duration: 3 Hour

MEREDITH CRABTREE