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45.40.148.117  Public Scan

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Submitted URL: https://r20.rs6.net/tn.jsp?f=001qj1RChBCjRfwVZbAqaNVGQjYR9qUm4mQcFa0SaANFjcmsQSZDVjTB4ObBPwayaX2YcHeUxCorRvtUo9Phn_B...
Effective URL: https://pathwise.com/download-in-a-regulatory-inspection-how-do-you-justify-training/
Submission: On September 30 via manual from PL — Scanned from DE

Form analysis 2 forms found in the DOM

GET https://pathwise.com/

<form role="search" method="get" class="et-search-form" action="https://pathwise.com/"> <input type="search" class="et-search-field" placeholder="Search …" value="" name="s" title="Search for:"></form>

POST #sf_form_salesforce_w2l_lead_27

<form id="sf_form_salesforce_w2l_lead_27" class="wpcf7-form top-aligned" method="post" action="#sf_form_salesforce_w2l_lead_27">
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          class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required required" name="last_name"></span></p>
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          class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required required" name="email"></span></p>
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        <div><iframe title="reCAPTCHA"
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</form>

Text Content

 * ePath Online Training
   * All eLearning Modules
   * Web Based Training for Compliance
     * Current Good Manufacturing Practices- cGMP
     * Quality System Regulation- QSR
     * Good Clinical Practices- GCP
     * Good Documentation Practices- GDP
     * Biologics
     * Combination Products
     * Electronic Records and Signatures
     * ISO 13485
     * EU MDR 2017/745
   * Web Based Training for Quality Systems
     * Intro to Investigations & CAPA
     * Intro to Technical Writing Principles
     * Intro to Quality Risk Management
     * Intro to Quality Change Control
     * Intro to Design Control
     * Intro to Human Factors and Performance
     * Inspection Readiness
   * Web Based Training for Productivity
     * Effective Meeting Management
     * Microproject Management Web Based Training
   * Webinars
     * Featured Webinar
     * Webinar Memberships
     * On Demand Webinars
 * Accreditation
   * Digital Badges from PathWise
 * Online Universal License
 * Virtual Instructor Led Training
   * Investigations and CAPA Training
     * CAPA Training for GCP
     * Role Based Training for Investigations and CAPA
     * Root Cause Investigation Training
     * Effectiveness Checks Training
     * Interviewing Skills Training
     * Quality Event Management Training
     * Conducting Out of Specification (OOS) Investigations Training
     * Complaint Handling Training
   * Technical Writing Principles
     * Documenting Investigations
     * Writing Standard Operating Procedures (SOPs)
     * Writing Validation Documents
     * Writing for Change Control
   * Human Factoring Records Training
   * Quality Risk Management Training
     * Risk Management for Med Device
     * Risk Management for Pharma
     * FMEA Training
     * Fault Tree Analysis (FTA) Training
   * Quality Change Control Training
     * Writing for Change Control
   * Lead Auditor Training
   * Inspection Readiness Training
   * Quality Systems and cGMP
   * Train the Trainer
   * Trainer Certification
     * Certified Trainer FAQ’s
   * Quality System Consulting
     * Remediation
     * Qualification
     * Coaching
 * Client Stories
 * About Us
   * Contact Us
   * White Papers and Help Tools
     * PathWise Partner White Papers and Help Tools
   * Events
     * Virtual: March 23-26, 2021
     * Virtual: September 27-30, 2021
     * Switzerland: July 2022
   * PathWise Management Team
   * PathWise Staff
   * PathWise Team of Trainers
   * Careers
   * PathWise Industry News

Select Page
 * ePath Online Training
   * All eLearning Modules
   * Web Based Training for Compliance
     * Current Good Manufacturing Practices- cGMP
     * Quality System Regulation- QSR
     * Good Clinical Practices- GCP
     * Good Documentation Practices- GDP
     * Biologics
     * Combination Products
     * Electronic Records and Signatures
     * ISO 13485
     * EU MDR 2017/745
   * Web Based Training for Quality Systems
     * Intro to Investigations & CAPA
     * Intro to Technical Writing Principles
     * Intro to Quality Risk Management
     * Intro to Quality Change Control
     * Intro to Design Control
     * Intro to Human Factors and Performance
     * Inspection Readiness
   * Web Based Training for Productivity
     * Effective Meeting Management
     * Microproject Management Web Based Training
   * Webinars
     * Featured Webinar
     * Webinar Memberships
     * On Demand Webinars
 * Accreditation
   * Digital Badges from PathWise
 * Online Universal License
 * Virtual Instructor Led Training
   * Investigations and CAPA Training
     * CAPA Training for GCP
     * Role Based Training for Investigations and CAPA
     * Root Cause Investigation Training
     * Effectiveness Checks Training
     * Interviewing Skills Training
     * Quality Event Management Training
     * Conducting Out of Specification (OOS) Investigations Training
     * Complaint Handling Training
   * Technical Writing Principles
     * Documenting Investigations
     * Writing Standard Operating Procedures (SOPs)
     * Writing Validation Documents
     * Writing for Change Control
   * Human Factoring Records Training
   * Quality Risk Management Training
     * Risk Management for Med Device
     * Risk Management for Pharma
     * FMEA Training
     * Fault Tree Analysis (FTA) Training
   * Quality Change Control Training
     * Writing for Change Control
   * Lead Auditor Training
   * Inspection Readiness Training
   * Quality Systems and cGMP
   * Train the Trainer
   * Trainer Certification
     * Certified Trainer FAQ’s
   * Quality System Consulting
     * Remediation
     * Qualification
     * Coaching
 * Client Stories
 * About Us
   * Contact Us
   * White Papers and Help Tools
     * PathWise Partner White Papers and Help Tools
   * Events
     * Virtual: March 23-26, 2021
     * Virtual: September 27-30, 2021
     * Switzerland: July 2022
   * PathWise Management Team
   * PathWise Staff
   * PathWise Team of Trainers
   * Careers
   * PathWise Industry News




WHITE PAPER: IN A REGULATORY INSPECTION HOW DO YOU JUSTIFY TRAINING?

How do you justify training in your organization? The FDA defines expertise as a
combination of experience, education, and training. The ability to prove to the
FDA that a company has a process, approach, and ability to execute training is
key to meeting the 21CFR Part 211 or Part 820 – Current Good Manufacturing
practice for finished pharmaceuticals – Subpart B – Organizational and
Personnel, Sec. 211.25 Personnel qualification standard or for Medical Devices
in Section 820.25, Personnel. Demonstrating how training is created, delivered,
tracked and sustained is important to ensure that the process developed to
manufacture drug products is reliable and reproducible to ensure safety and
efficacy of drug products for consumers.

Get our FREE white paper here!



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