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Langue du site : Français - English
Réf : 28894
Evènement :Design for Quality and Compliance

Date :Mercredi 13 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 2-hour webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance result. This webinar can help you create a design control process that is a competitive strength for your company.

Objectives

  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Understand the Design Control Process
  • Understand the expectations of “risk analysis”
  • Identify best practices and tools
  • Prepare a Plan for Inspection Readiness

Program

  • Overview and Definitions
  • FDA Expectations, Regulations
  • Design Control Process
  • Design and Development Planning
  • Design Inputs
  • Design Outputs
  • Verification
  • Validation
  • Risk Analysis (Management)
  • Design Review
  • Design Transfer
  • Design Changes
  • Design History File
  • Linkages to other quality system regulations and requirements
  • Lessons Learned and Enforcement Case Studies
  • Best Practices
  • Preparing for an FDA or NB Inspection

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

Design for Quality and Compliance Management
design control, design control process, design control guidance, design control compliance, design control case studies, compliant design control process, fda design control, design controls for medical devices
Professionnels, R&D Engineers and Scientists R&D Managers and Directors Product Development Managers Product Development Project Leaders Individuals participating in Product Design and Development Individuals participating in design changes and failure investigations Regulatory Affairs Quality Engineers Design Quality Engineers CAPA Specialists Compliance Specialists Auditors Senior Management
10 -- --
English

Divers

Pour plus d'informations sur Design for Quality and Compliance, veuillez contacter ComplianceOnline

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