Download any of our FREE resources and White Papers! INVESTIGATIONS & CORRECTIVE AND PREVENTIVE ACTION (CAPA) WHITE PAPERS 6 Ways to Identify Root Cause QuicklyCorrective Action or Correction- Which is it? Interview Skills For InvestigatorsBest Practices for Effectiveness Checks For CAPA Avoid Traps When Using the 5 Why'sOut of Specification (OOS) Investigations: Back To Basics Does Your Culture Need a CAPA?Establishing a Compliant and Risk Based CAPA System Conducting InvestigationsWhy do we Have Repeat Investigations? It's OK To Document an Event Without Looking for Root CauseWhy Do We Triage? Examples of Conducting Investigations Why Trending is Important for RCA and Breakthrough Improvement Three Key Statements for InvestigationsHow to Set Up Effectiveness Checks Seven Things to Consider in Deviation InvestigationsCAPA Summaries 7 Questions for Effectiveness ChecksWhy is Is Is Not Standard Work for Problem SolvingAdverse Event Reporting Standard Work for Problem SolvingNonconforming Materials Report: Example Capturing JustificationsNonconforming Materials Reporting The Value of a Compliant, Effective, and Efficient CAPA SystemWrite Effective Root Cause Statements to Ensure Strong CAPAs Out of Tolerance Calibrations- Assessing the ImpactOut of Specification (OOS) Investigation Checklist Effective Management of Supplier Corrective Action RequestsWhat 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 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 RolesImplementing a Competency Based Training System The Importance of Role Based Training &amp;amp;amp;lt;/p&amp;amp;amp;gt;<br />&amp;amp;amp;lt;div style=”display:inline;”&amp;amp;amp;gt;<br />&amp;amp;amp;lt;img height=”1″ width=”1″ style=”border-style:none;” alt=”” src=”//googleads.g.doubleclick.net/pagead/viewthroughconversion/1070776312/?value=0&amp;amp;amp;amp;amp;guid=ON&amp;amp;amp;amp;amp;script=0″/&amp;amp;amp;gt;&amp;amp;amp;lt;/div&amp;amp;amp;gt;<br />&amp;amp;amp;lt;p&amp;amp;amp;gt; REGULATORY AND COMPLIANCE INFORMATION FDA Audit ExemptionsCurrent Regulatory Trends in the Area of Consent Decrees Top FDA 483 ObservationsInspectional Observation Trends for Medical Device Changing Regulatory Landscape: What Influenced the New EU MDRGuidance Document for industry and cGMP Requirements for Combination Products EU MDR 2017- Your Frequently Asked Questions AnsweredFDA 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 13485:20168 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 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 SuccessGuidelines for the Selection of a Proper Sampling Plan Risk Based Supplier QualificationUtilizing Simple Tasks for Success Is it Document Control or Document Management?Effective Batch Record Review Practices Design History Files – ExamplesManagement Commitment Adverse Event ReportingEnvironmental Monitoring Implementing an Effective Return Material Authorization ProgramThe 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 validationValue in Risk Management How Risk Management Tools Improve Product Risk and Trending in Design Control Risk Based Decision Making in a Quality SystemThe Need for Effective Risk Management Establishing a Compliant and Risk- Based CAPA SystemRisk Based Supplier Qualification Capturing JustificationsMedical 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 AnalysisFMEA vs. FTA 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 ExemptionsMDSAP- The Program that Came to Stay Audit Checklist for Medical Devices and PharmaMDSAP Audit Preparation &amp;amp;lt;/p&amp;amp;gt;<br />&amp;amp;lt;div style=”display:inline;”&amp;amp;gt;<br />&amp;amp;lt;img height=”1″ width=”1″ style=”border-style:none;” alt=”” src=”//googleads.g.doubleclick.net/pagead/viewthroughconversion/1070776312/?value=0&amp;amp;amp;amp;guid=ON&amp;amp;amp;amp;script=0″/&amp;amp;gt;&amp;amp;lt;/div&amp;amp;gt;<br />&amp;amp;lt;p&amp;amp;gt; QUALITY SYSTEMS WHITE PAPERS FDA Quality Metrics Quick Reference GuideRequired and Optional Quality Metrics Global Quality Standards Implementation and Roll OutApplication of Codes for Quality Metrics Reporting Continuous Quality Improvement to Avoid RemediationEffective Quality System Management Keeping Good Quality RecordsQuality 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 Follow us! LEARN MOREPathWise White Papers About Us PathWise Management Team PathWise Staff PathWise Team of Trainers Contact Us!Questions about our training? Ready to schedule your session? First name: * Last name: * Email: * Phone: * Company: * Title: * Details?: * * These fields are required.
