Your event should be here ! To publish, manage, promote... To learn or to be formed ... Online registrations

Site language : English - Français
Ref : 28894
Event :Design for Quality and Compliance

Date :Wednesday February 13th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

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

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

To access the information you need to be connected. Creating an account is easy and free!

Log to your account
Register on Doctorama

Details

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
Professionals, 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

Other

For more information on Design for Quality and Compliance, plsase contactr ComplianceOnline

To display announcer website, obtain a letter of invitation, you must be logged

Log to my account
Register on Doctorama


Recommend this event