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INVESTIGATIONS & CORRECTIVE AND PREVENTIVE ACTION (CAPA) WHITE PAPERS
6 Ways to Identify Root Cause Quickly	Corrective Action or Correction- Which is it?
Interview Skills For Investigators	Best Practices for Effectiveness Checks For CAPA
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?
It's OK To Document an Event Without Looking for Root Cause	Why Do We Triage?
Examples of Conducting Investigations	Why Trending is Important for RCA and Breakthrough Improvement
Three Key Statements for Investigations	How to Set Up Effectiveness Checks
Seven Things to Consider in Deviation Investigations	CAPA Summaries
7 Questions for Effectiveness Checks	Why is Is Is Not
Standard Work for Problem Solving	Adverse Event Reporting
Standard Work for Problem Solving	Nonconforming Materials Report: Example
Capturing Justifications	Nonconforming Materials Reporting
The Value of a Compliant, Effective, and Efficient CAPA System	Write Effective Root Cause Statements to Ensure Strong CAPAs
Out of Tolerance Calibrations- Assessing the Impact	Out of Specification (OOS) Investigation Checklist
Effective Management of Supplier Corrective Action Requests	What to do about Human Error Deviations?

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
K.I.S.S. Your SOPs (Keep it Simple!...)
Three Key Statements for Investigations
Writing Effective Document Change Requests
"How To" Guide for Managing Data in Your Reports
Write Effective Root Cause Statements to Ensure Strong CAPAs
Writing Effective Deviation Investigations
Better Writing Through Assessment Tools
ALCOA: A Data Integrity Standard

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

REGULATORY AND COMPLIANCE INFORMATION
FDA Audit Exemptions	Current Regulatory Trends in the Area of Consent Decrees
Top FDA 483 Observations	Inspectional Observation Trends for Medical Device
Changing Regulatory Landscape: What Influenced the New EU MDR	Guidance Document for industry and cGMP Requirements for Combination Products
EU MDR 2017- Your Frequently Asked Questions Answered	FDA Regulator Paths for Combination Products
Marching to March-2019: ISO 13485:2016 Update Overview	The MDSAP Program (In a Large Nutshell)
Transition Planning Guide for ISO 13485:2016	8 Key Practices to aid in Board of Health (BOH) Responses
Six Considerations for Good Clinical Practices (GCP)

Quality Change Control White Papers
Is Your Change Control System Under Control?
Take Control
Change Control Classifications
Justifications
Managing Changes Impacting Design
Document Change Control- Examples

GENERAL TOPIC WHITE PAPERS
Conducting Effective and Compliant Validations	Conducting Effective and Compliant Validations: An Example
Capturing Justifications in Change Control, Risk Assessments, Validations, and Investigations	Complaint Handling
The False Claim Act: Sustained Use as the Government’s Primary Enforcement Tool	Key Components of a Compliant Product Complaint Handling System
Inspectional Observation Trends for Medical Device	Human Performance Improvement
Proper Execution of Annual Product Reviews	Human Factoring Records
The PDCA cycle and Management System Standards	Achieving Success and Compliance in the Supply Chain
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 Charting	What to do about Human Error Deviations?
Design Transfer Success – From Product Development to Production	The Relentless Pursuit and Elimination of Waste
The Pilot Run Process	The Need For Capability Analysis
Implementation and Management of Data Integrity	Introduction to Management Reviews
Postmarket Surveillance and Feedback	Data Visualization
Effective Batch Record Review Processes	Medical Device Classification and Applicable Controls
Writing Effective Document Change Requests	The Importance of Evaluating your Measurement System
Creating a Culture of Quality to Benefit Compliance	Don't Be (ONLY) Compliant!
Making Your Kaizen Event a Success	Guidelines for the Selection of a Proper Sampling Plan
Risk Based Supplier Qualification	Utilizing Simple Tasks for Success
Is it Document Control or Document Management?	Effective Batch Record Review Practices
Design History Files – Examples	Management Commitment
Adverse Event Reporting	Environmental Monitoring
Implementing an Effective Return Material Authorization Program	The Importance of Equipment Maintenance in Assuring Product Quality
The Perception of Quality

QUALITY RISK MANAGEMENT WHITE PAPERS
The commonalities between risk management and design verification, design validation and process validation	Value in Risk Management
How Risk Management Tools Improve Product	Risk and Trending in Design Control
Risk Based Decision Making in a Quality System	The Need for Effective Risk Management
Establishing a Compliant and Risk- Based CAPA System	Risk Based Supplier Qualification
Capturing Justifications	Medical Device Risk Management
ISO TR 24971- What is this document and Why do I need it?	Value in Risk Management
How to Perform a Successful Failure Modes and Effects Analysis	FMEA vs. FTA

AUDITING WHITE PAPERS
In a Regulatory Inspection, How do You Justify Training	MDSAP Program in a (large) Nutshell
Preparation for Hosting Third Party Audits	Six 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 Environment	Supplier Audits: Keeping it Simple
What Team Do You Need in Place for an FDA Audit?	Pre-Approval Inspection (PAI) Overview
Auditing Checklist	Interview Skills for Investigators
FDA Audit Exemptions	MDSAP- The Program that Came to Stay
Audit Checklist for Medical Devices and Pharma	MDSAP Audit Preparation

QUALITY SYSTEMS WHITE PAPERS
FDA Quality Metrics Quick Reference Guide	Required and Optional Quality Metrics
Global Quality Standards Implementation and Roll Out	Application of Codes for Quality Metrics Reporting
Continuous Quality Improvement to Avoid Remediation	Effective Quality System Management
Keeping Good Quality Records	Quality vs. Regulatory- Key Similarities and Differences

HUMAN PERFORMANCE AND IMPROVEMENT
4 Key Activities for Proactive Human Factoring of Records
What to do about Human Error Deviations?
The Impact Feedback Shares in Human Performance and Factoring
White Paper: Human Performance Improvement
Human Factoring Records

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