2014 - 21 CFR 820 Best Practice, Requirements Traceability From Source Documents Through Design Validation

Instructor: Russell Pizzuto
Description:
This seminar will show you how to effectively integrate requirements tractability into your product development process. This systematic process links all User Needs, Intended Uses, regulatory requirements and functional requirements from source documents through Design Inputs, Design Output, Design Verification and Design Validation.
This best practice will help ensure that your development programs and design changes have met all project design requirements related to safetyand effectiveness, and help demonstrates 21 CFR 820 Design Controls compliance.
It is challenging to ensure that all design requirements related to product safety and effectiveness are met. You can’t afford to be in a position where your design control system is weak and does not effectively show how each design, regulatory and safety requirement has been satisfied. This is essentialfor both developing/maintaining safe and effective products, and to demonstrating QSR 21CFR 820 compliance to the FDA.
Objectives of the Presentation:
The seminar will focus on understanding:
How to define source document and design requirements
How to link to source documents: intended use, user needs, risk analysis, product spec, industry standards…
How to create a Traceability Matrix that traces:
Source document to Design Input (including Essential Design Inputs)
Design Inputs to Design Outputs to Design Verification and to Design Validation
Integration into a product development process and the DHF
How to use traceability in new product development and design changes
How this process systematically creates objective evidence and how to easily produce it during an audit
Who can Benefit:
Project Managers
Quality Managers and Staff
R&D, Product Development and Sustaining Engineering, Managers and Staff
Regulatory and Compliance Managers and Staff
Compliance and Product Development Consultants
Anyone with Product Development, Risk Management, Regulator or Quality Assurance Responsibilities
Register Now:
http://www.onlinecompliancepanel.com/ecommerce/web...
Online Compliance Panel LLC
38868 Salmon Ter
Fremont, CA, USA
94536
Toll Free: 1-510-857-5896