Medical Device - Eventura

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

3-HOUR VIRTUAL SEMINAR ON ANALYTICAL METHOD VALIDATION AND TRANSFER

Duration: 3 Hour

FDA’S RECENT REGULATION ON THE USE OF SOCIAL MEDIA

CAROLYN TROIANO

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 3 Hour

3-HOUR VIRTUAL SEMINAR ON IQ, OQ, PQ IN THE VERIFICATION AND VALIDATION PROCESS

Duration: 3 Hour

EQUIPMENT QUALIFICATION AND PROCESS VALIDATION

Duration: 60 Minutes

UNDERSTANDING AND IMPLEMENTING A QUALITY BY DESIGN (QBD) PROGRAM

Steven Laurenz ‎

Duration: 60 Minutes

HOW TO DEPLOY ROOT CAUSE AND CAPA TO MINIMIZE HUMAN ERROR

Dr. Ginette Collazo

Duration: 90 Minutes

A RISK BASED APPROACH TO IT INFRASTRUCTURE QUALIFICATION, COMPLIANCE & CONTROL

CAROLYN TROIANO

Duration: 3 Hour

FDA VS HEALTH CANADA - SIMILARITIES AND DIFFERENCES BETWEEN THE TWO REGULATORY BODIES

Duration: 90 Minutes

US FDA DRUG REVIEW AND APPROVAL PROCESS

Duration: 60 Minutes

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

JOHN E. LINCOLN

Duration: 3 Hour

Auditing Computer Systems for Part 11 and International Compliance

CAROLYN TROIANO

Duration: 90 Minutes

MEDICAL DEVICE HAZARD ANALYSIS FOLLOWING ISO 14971

Edwin Waldbusser

Duration: 90 Minutes

Validation Sampling Plans and Setting Acceptance Criteria

Duration: 60 Minutes

Quality in Technology Transfer Projects

Duration: 60 Minutes

MDSAP Audits – All You Need to Know

Duration: 75 Minutes

How to get a 510(k) for a Machine Learning Product

Edwin Waldbusser

Duration: 60 Minutes

3-Hour Virtual Seminar on GAMP® 5 Second Edition – The changes and its impacts that you should know

CAROLYN TROIANO

Duration: 3 Hours

How FDA trains its Investigators to Review CAPA and How should you prepare

CHARLES H. PAUL

Duration: 60 Minutes

Effective Design Control (21 CFR Part 820.30)

JOHN E. LINCOLN

Duration: 90 Minutes

FDA REGULATION OF ARTIFICIAL INTELLIGENCE / MACHINE LEARNING

Edwin Waldbusser

Duration: 60 Minutes

Step-by-Step approach for Setting up FDA Audit Ready Quality Management System (QMS) – Case Studies based training

Duration: 90 Minutes

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

JOHN E. LINCOLN

Duration: 90 Minutes

3-Hour Virtual Seminar on 510(k) and PMA Submissions Process

CHARLES H. PAUL

Duration: 3 Hours

A to Z of Supplier Management in the Medical Device Industry

Duration: 90 Minutes

How to select Software for a Regulated Environment

Duration: 2 Hour

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices

Duration: 90 Minutes

Cyber Security Planning for Medical Devices

CASPER E. ULDRIKS

Duration: 60 Minutes

Training Requirements under FDA’s Quality System Regulation

CASPER E. ULDRIKS

Duration: 60 Minutes

Clinical Trials for The Intended Use of Software as a Medical Device

CASPER E. ULDRIKS

Duration: 60 Minutes

Managing the FDA form “483”: Inspection Observations

CASPER E. ULDRIKS

Duration: 60 Minutes

Avoid Reporting Cybersecurity Updates and Patches to the FDA

CASPER E. ULDRIKS

Duration: 60 Minutes