Online Conference Risk-based Software Validation for Quality System software and Medical Device Data Systems (MDDS)

Website https://compliance2go.com/product/?pid=CP2014-417 | Edit Freely

Category Medical Device

Deadline: February 18, 2015 | Date: February 19, 2015

Venue/Country: Online, U.S.A

Updated: 2015-01-28 15:41:45 (GMT+9)

Call For Papers - CFP

By applying risk analysis to software validation tasks, the amount of validation effort can be based on the risk, thus reducing validation effort for low and moderate risk software. This webinar on software validation will provide you the information you need to establish as system for validating quality-related software under FDA’s Quality System Regulation/cGMP. This includes validating any software used for manufacturing and testing of medical devices and used in your quality system. In addition it will cover the approaches to validating Medical Device Data Systems software. This approach to software validation is also applicable to software used under GLP, GCP, and cGMP.

Why you should attend

Under Medical Device cGMP, 21 CFR820.70 (i), software used in manufacturing or testing of medical devices or in the quality system must be validated for its intended use. 21 CFR 11, Electronic Records, Electronic Signatures, also has software validation requirements. Product software is required to be validated as part of design controls (21 CFR 820.30). The FDA has recently down-classed MDDS to Class I, but requires that these system still follow design controls, and thus software validation. This presentation will focus on how software, including MDDS, can be validated for its intended use, including how to establish procedures in your quality system to cover software validation activities.

Description of the topic

This presentation will provide information on software validation necessary for quality management, as well as for quality and other engineers who design and preform software validation activities.

This presentation will provide an understanding of software validation for software used under GLP, GCP, and cGMP and validation of software in MDDS products. Information will be provided to make sure your software validation system meets FDA regulations and guidelines.

Developing or updating your software validation system to one based on risk

Complying with FDA requirements for manufacturing, testing and quality software

Complying with FDA requirements for validation of software in MDDS products

Methods of creating software requirements documents

Principles for creating a software risk analysis

Elements required in a software validation study

Areas Covered In the Seminar

The types of software that must be validated according to the FDA

How to create or update a software validation system to meet software validation requirements in the least burdensome manner

Defining Software requirements

Defining and documenting software risk

The elements of a quality system software validation program

The elements in a software validation study

Who will benefit

This webinar will provide valuable assistance to all personnel in:

Quality Managers and Directors

Regulatory Affairs professionals

Quality Engineers

Development Engineers

Design Engineers for MDDS products

Validation engineers

Quality auditors

Manufacturing or Operations Managers

Medical Device IT Managers

Free documents

FDA Software Validation Slides 2010

FDA Guide-Software Validation-2002

FDA Guide-OTS-Software-1999

FDA Guide-Cybersectrity-Networked-OTS-2005

FDA MDDS Classification Rule-2011

FDA-21 CFR 880.6310 MDDS-2011

Webinar Includes:

Q/A Session with the Expert to ask your question

Copy of PowerPoint slides (PDF print only)

60 Minutes Live Presentation

Certificate of Attendance