Sunshine Act Reporting - Clarification for Clinical Research

Impact Assessments For Supplier Change Notices

Batch Record Review and Product Release

Risk Analysis in the Medical Device Design Process

Human Error Reduction Techniques for Floor Supervisors

Validation Statistics for Non-Statisticians

Project Management for Non-Project Managers - Scheduling your Project

How to Write Procedures to Avoid Human Errors

Validation Sampling Plans

FDA Audit Best Practices - Do's and Don'ts

Project Management for Non-Project Managers - How to communicate project actions and progress - conducting effective project review meetings

COTS, Cloud, and SaaS Systems and FDA Validation Compliance

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

Design Verification, Validation and Testing for Medical Devices

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration

Impact of machine learning in pre-clinical research and regulatory compliance

Design Control for Medical Devices and Combination Products

Successful Supplier Audits

Medical Device Hazard analysis following ISO 14971

Risk Assessment for Medical Devices

Project Management for Non-Project Managers

Implementing a Change Control Quality System Successfully

Human Error Reduction in GMP Related Environments

Human Error Reduction in GMP Manufacturing Environments for Floor Supervisors

Medical Device Software Per IEC 62304

Software Validation for the New FDA Inspections

Proper Execution of Annual Product Reviews

Developing an Effective CAPA Management and Root Cause Analysis System

Risk Management Under ISO 14971 Integrating Concepts From IEC 62304 and ANSI 62366

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Understand CERT Findings and What Your Organization Should Be Monitoring

FDAs Final Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List

FDA Regulations for Pharmaceutical Good Manufacturing Practice (GMP)

Best practices for purchasing and supplier controls in the medical device industry

Gaining And Re-Establishing Control Of Your Cleanroom

Preparing And Investigating Oos/Oot Results In A Regulated Environment