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TRAINING WHITE PAPERS
Coaching to Improve Training Results
Benefits of e-Learning
The Advantages of Certifying In-House Trainers
The Unlocked Potential of your Training Resources
To Train or Not to Train?
In a Regulatory Inspection, How do you Justify Training?
Is our Subject Matter Expert (SME) the right choice to become our in-house trainer?
How to Source Training
Do You Need a Trainer or a Training Consultant

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 ChainImplementation and Management of Data Integrity
Design History Files – Design Control Documentation
Device Master Records and Medical Device Files – How Do They Compare?
The Impact Feedback Shares in Human Performance and Factoring
Device History Records – What Should They Include?
The Power of Control ChartingWhat to do about Human Error Deviations?
Design Transfer Success – From Product Development to Production
The Relentless Pursuit and Elimination of Waste
Conducting Effective and Compliant Validations: Example

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
Supplier Audits- Conducting Desktop Audits
Six Steps to Plan and Conduct a Management System Audit
MDSAP Program in a (large) Nutshell

PathWise White Papers

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