Conference Description:

Overview

FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than the validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.
How to plan and conduct a risk-based validation will be explained. The overall risk for a computer system is a combination of software complexity and product risk as determined by probability, severity and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. You'll learn how to integrate risk-based supplier evaluation into the validation process.
Validation Master plan and System Validation Plans will be explained
Testing, based on risk, includes requirements validation and IQ, OQ and PQ. A procedure for each level of complexity and risk will be described.

Why should you attend this webinar?

Validation of computer system software is completely different than the validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission.

You will learn in detail:

How to manage the validation process

Validation life cycle models and Validation Plan contents

How to determine the complexity category of your system based on GAMP 5 principles

How to evaluate risk level using GAMP 5 modifications to the ISO 14971 procedure

What level of testing is necessary based on software complexity and risk

Integrating software supplier evaluation into the validation process

What documentation is necessary

how to minimize documentation to reduce costs based on risk

How to plan and conduct IQ, OQ, and PQ

Areas Covered in the Session:

Validation strategy

Requirements documentation

Complexity and risk analysis

Creating a detailed test plan based on risk

Supplier qualification

IQ, OQ, and PQ

Who can Benefit:

Computer system developers

Systems development engineers

QA/ QC

Lab Managers and Analysts

Production Managers

Engineering managers

Speaker:

Edwin Waldbusser is Keynote Speaker at ComplianceKey. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices.

Register: https://www.compliancekey.us/webinarDeta ils?industryId=3&webinarid=1418&speakeri d=48

Compliance Key

Visit: https://www.compliancekey.us/life-scienc e-and-healthcare

Phone: +1 717-208-8666

Email: [email protected]