Prove 21 CFR 820 Compliance Using Requirements Traceability

Why Should You Attend:

It is challenging to ensure that all requirements are met and to prove 21 CFR 820 compliance in an audit. Consider how difficult it is to proving compliance during an audit when the details are no longer fresh in your mind or how challenging it is for a new associate to find critical information required for a design change or an FDA audit year after product release.

You can’t afford Quality System Processes that are weak and do not effectively show how each design, regulatory and safety requirement has been satisfied and managed throughout the device lifecycle.

This seminar will show you how to effectively integrate Requirements Tractability into your quality system processes. Requirements Tractability Processes systematically collects objective evidence and links User Need, Intended Use, Risk Management, Regulatory and Functional Requirements from source documents through Design Controls. Manufacturing and post-production processes interface with the requirements traceability process completing linkage across the device lifecycle.

Areas Covered in the Webinar:

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 to connect Critical to Safety Attributes to Manufacturing
• How Design Changes and Risk Analysis use the traceability matrix
• How this process systematically creates objective evidence and how to easily produce it during an audit

Who Will Benefit:

• Quality managers and staff
• Regulatory and Compliance managers and staff
• Product Development and Sustaining Engineering, managers and staff
• Project managers
• Compliance and Product Development Consultants
• Anyone with Product Development, Risk Management, Regulator or Quality Assurance responsibilities

Russell Pizzuto
President, PPRE Consulting LLC

Russell Pizzuto has 40 year of engineering and management experience with 14 years in medical device design, manufacturing and regulatory compliance. Early in Mr. Pizzuto career he developed hundreds of new consumer and industrial products for fortune 500 companies. As Global Director of Engineering for a major medical device manufacturer with teams in USA, Europe, China and Mexico he delivered Class I and Class II medical device projects.

For the last 5 years he has served as President of PPRE Consulting, specializing in Product, Project and Regulatory Engineering. He holds a Medical Device certificate from the Regulatory Affairs Professionals Society (RAPS), has work on the FDA’s Hospital Bed Safety Work Group and serves as an expert witness in Hospital Bed Safety litigation. Mr. Pizzuto has most recently focused on helping clients under FDA legal action to bring their Design Control and Risk Management Systems into compliance.

Follow us :