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TRAINING WHITE PAPERS
Coaching to Improve Training ResultsDo You Need a Trainer or a Training Consultant
Benefits of e-LearningHow to Source Training
The Advantages of Certifying In-House TrainersIs our Subject Matter Expert (SME) the right choice to become our in-house trainer?
The Unlocked Potential of your Training ResourcescGMP Annual Training
To Train or Not to Train? In a Regulatory Inspection, How do you Justify Training?
Qualification of Key Roles

GENERAL TOPIC WHITE PAPERS
Conducting Effective and Compliant ValidationsConducting Effective and Compliant Validations: An Example
Capturing Justifications in Change Control, Risk Assessments, Validations, and InvestigationsComplaint Handling
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
Proper Execution of Annual Product ReviewsHuman Factoring Records
The PDCA cycle and Management System StandardsAchieving Success and Compliance in the Supply Chain
Design History Files – Design Control DocumentationDevice Master Records and Medical Device Files – How Do They Compare?
The Impact Feedback Shares in Human Performance and FactoringDevice History Records – What Should They Include?
The Power of Control ChartingWhat to do about Human Error Deviations?
Design Transfer Success – From Product Development to ProductionThe Relentless Pursuit and Elimination of Waste
The Pilot Run ProcessThe Need For Capability Analysis
Implementation and Management of Data IntegrityIntroduction to Management Reviews
Postmarket Surveillance and FeedbackData Visualization
Effective Batch Record Review ProcessesMedical Device Classification and Applicable Controls
Writing Effective Document Change RequestsThe Importance of Evaluating your Measurement System
Creating a Culture of Quality to Benefit ComplianceDon't Be (ONLY) Compliant!
Making Your Kaizen Event a Success

AUDITING WHITE PAPERS
In a Regulatory Inspection, How do You Justify TrainingMDSAP Program in a (large) Nutshell
Preparation for Hosting Third Party AuditsSix Steps to Plan and Conduct a Management System Audit
Are You Ready? Prepare and Practice for Inspection Readiness!Supplier Audits- Conducting Desktop Audits
Managing Third Party Audits in a Regulated EnvironmentSupplier Audits: Keeping it Simple
What Team Do You Need in Place for an FDA Audit?Pre-Approval Inspection (PAI) Overview
Auditing ChecklistInterview Skills for Investigators
FDA Audit Exemptions

PathWise White Papers

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