Medical Device - Eventura

GLP Data Integrity - Ensuring Accurate Reliable Results

CHARLES H. PAUL

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

How to Ace an FDA Meeting - Preparation and Conduct

CHARLES H. PAUL

Duration: 90 Minutes

FDA Warning Letter - Consent Decree Software Validation

MEREDITH CRABTREE

Duration: 90 Minutes

Failure Investigation and Root Cause Analysis - Tools and Techniques

JOHN E. LINCOLN

Duration: 90 Minutes

Design Verification and Validation

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

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

CAROLYN TROIANO

Duration: 90 Minutes

Preparing a 510(k) Premarket Notification

JOHN E. LINCOLN

Duration: 90 Minutes

Conducting Successful Complaint Investigations In Regulated Industries

MEREDITH CRABTREE

Duration: 90 Minutes

FDA Labeling and UDI Essentials for Medical Products

Duration: 90 Minutes

US FDA'S AI Framework For Medical Devices

JOHN E. LINCOLN

Duration: 90 Minutes

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

CAROLYN TROIANO

Duration: 3 Hour

Master The Vendor Auditing Of Your Computer Systems Regulated By FDA

CAROLYN TROIANO

Duration: 90 Minutes

Writing Investigations That Meet Regulatory Requirements

CHARLES H. PAUL

Duration: 90 Minutes

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

CAROLYN TROIANO

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

Good Clinical Practices (GCP) Audit And Inspection Readiness

CHARLES H. PAUL

Duration: 90 Minutes

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

SCOTT R. THATCHER

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

Risk-Based Excel Spreadsheet Validation

CAROLYN TROIANO

Duration: 90 Minutes

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

MEREDITH CRABTREE

Duration: 90 Minutes

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

Preventive Maintenance And Calibrations - Regulatory Expectations And Best Practices

MEREDITH CRABTREE

Duration: 90 Minutes

Using Audit Trails To Support Part 11 Data Integrity Compliance

CAROLYN TROIANO

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

Design Control For Medical Devices And Combination Products

Duration: 60 Minutes

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

CAROLYN TROIANO

Duration: 90 Minutes

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

CHARLES H. PAUL

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 3 Hour

Data Integrity And Human Error

Dr. Ginette Collazo

Duration: 90 Minutes

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

CHARLES H. PAUL

Duration: 90 Minutes

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

Edwin Waldbusser

Duration: 60 Minutes

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

MEREDITH CRABTREE

Duration: 3 Hour

FDA/ICH Guideline Q9 (R1) On Quality Risk Management

MEREDITH CRABTREE

Duration: 90 Minutes

Good Clinical Practices Review of ICH E6 (R3) Latest Guidance

CHARLES H. PAUL

Duration: 60 Minutes

Innovative Strategies - Harnessing Design Controls For QMS Excellence

Duration: 90 Minutes

Medical Device Cybersecurity Following Latest FDA Guidance

Edwin Waldbusser

Duration: 60 Minutes

Auditing Laboratory Data Systems

Duration: 90 Minutes

HANDLING MEDICAL DEVICE COMPLAINTS & CAPA

Edwin Waldbusser

Duration: 60 Minutes