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

This medical device software validation webinar will provide guidance on how to establish a software system validation system for complying with FDA’s Quality System Regulation/cGMP.

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 820.30 also requires product software to be validated as part of design controls. The FDA has recently down-classed Medical Device Data Systems (MDDS) to Class I, but requires that these system still follow design controls, and thus software validation.
This 90-minute webinar on software validation will provide the information required to establish a system for validating software under FDA’s Quality System Regulation/cGMP. This includes validating any software used for manufacturing and testing of medical devices. In addition it will cover the approaches to validating Medical Device Data Systems software.
Learning Objectives:
• 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

Quality management personnel,Regulatory affairs personnel,Quality engineers,Design engineers for MDDS products,Validation engineers, Quality auditors

Instructor: Betty Lane

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