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DOWNLOAD GENERAL QUALITY SYSTEM TOPIC WHITE PAPERS 
"Standard Work" For Problem SolvingContinuous Quality Improvement to Avoid Remediation
Adverse Event ReportingComplaint Handling
FDA Quality Metrics Quick Reference GuideRequired and Optional Quality Metrics
Nonconforming Materials Reports – Compliance and ImplementationMedical Device Classification and Applicable Controls
The False Claim Act: Sustained Use as the Government’s Primary Enforcement ToolKey Components of a Compliant Product Complaint Handling System
Inspectional Observation Trends for Medical DeviceHuman Performance Improvement
Current Regulatory Trends in the Are of Consent DecreesHuman Factoring Records
Conducting Effective and Compliant ValidationsProper Execution of Annual Product Reviews
Capturing Justifications in Change Control, Risk Assessments, Validations, and InvestigationsMarching to March 2019 – ISO 13485:2016 Update Overview
cGMP Annual TrainingThe PDCA cycle and Management System Standards
Achieving Success and Compliance in the Supply Chain

FDA TOPICS
Current Regulatory and Compliance Trends in the Area of Consent Decree in Pharmaceutical, Medical Device and Biologics
FDA Audit Exemptions
Top FDA 483 Observations

DOWNLOAD INVESTIGATIONS & CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) WHITE PAPERS
Interview Skills For Investigators
Best Practices for Effectiveness Checks For CAPA
6 Ways to Identify Root Cause Quickly
Avoid Traps When Using the 5 Why's
Out of Specification (OOS) Investigations: Back To Basics
Does Your Culture Need a CAPA?
Establishing a Compliant and Risk Based CAPA System
Conducting Investigations
Why do we Have Repeat Investigations?

DOWNLOAD TECHNICAL WRITING WHITE PAPERS
Technical Writing Style Guide
Writing Documents from Different Perspectives and Managing Data in your Reports
Make Documents Easy for Your Reader
Your Good Documentation Practices (GDP) Legacy
Plain Writing: It Works!
Writing in a Cross Cultural Business Environment
Human Factoring Records
Conducting Effective and Compliant Validations

DOWNLOAD QUALITY RISK MANAGEMENT WHITE PAPERS
The commonalities between risk management and design verification, design validation and process validation
Risk Based Decision Making in a Quality System
Establishing a Compliant and Risk- Based CAPA System

QUALIFICATION OF KEY ROLES WHITE PAPERS
In a regulatory inspection how do you justify training?
Why is Qualification of Key Roles So Important in Our Regulated Industry?

DOWNLOAD AUDITING WHITE PAPERS
In a Regulatory Inspection, How do You Justify Training
Preparation for Hosting Third Party Audits
Are You Ready? Prepare and Practice for Inspection Readiness!
Managing Third Party Audits in a Regulated Environment
What Team Do You Need in Place for an FDA Audit?
Auditing Checklist
FDA Audit Exemptions
Interview Skills for Investigators
Pre-Approval Inspection (PAI) Overview
Supplier Audits: Keeping it Simple





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