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Langue du site : Français - English
Réf : 28930
Evènement :Introduction to Root Cause Investigation for CAPA

Date :Jeudi 21 Février 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

Objectives

If you have reoccurring problems showing up in your quality systems, your CAPA system is not effective and you have not performed an in-depth root cause analysis to be able to detect through proper problem solving tools and quality data sources, the true root cause of your problem. Unless you can get to the true root cause of a failure, nonconformity, defect or other undesirable situation, your CAPA system will not be successful. Historically, 483s in the medical device industry related to CAPAs, are due to lack of inadequate root cause investigations, among other factors. This course focuses on the medical device industry and provides a basic understanding on:

  1. What are the FDA and ISO (13485:2016) requirements
  2. How is root cause analysis integrated into the CAPA process and risk management
  3. Challenges associated to root cause analysis
  4. Problem solving tools to use during the root cause analysis investigation
  5. Where to find objective evidence for this type of analysis 

Program

  • Understand the difference between a correction, corrective action and preventive action
  • Learn which medical device regulation and standard, apply to CAPA
  • Learn why root cause analysis is important
  • Understand the difference between a direct cause, a contributing cause and a true root cause
  • When to use root cause analysis during the CAPA process
  • Understand the association between root cause and risk management
  • Tools and quality data sources you may use during root cause analysis 

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

Introduction to Root Cause Investigation for CAPA Management
capa investigations, root causes analysis, iso 13485 requirements, fda capa requirements, capa training webinar
Professionnels, CAPA Owners Quality Assurance/ Quality Control Personnel Regulatory Compliance Professionals Document Control Personnel Regulatory Affairs Professionals Quality and Manufacturing Engineer Supplier Quality Managers Quality Auditors
10 -- --
English

Divers

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