Description

This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

Areas Covered in the Webinar:-

• Which data and systems are subject to 21 CFR Part 11 and Annex 11
• Why compliance makes good business sense.
• Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures.
• Requirements for local, SaaS, and cloud hosting
• The 6 Most Common Problems in FDA Software Validation & Verification.
• Strategies on how to avoid the most common problems.
• Advice on successful validation project staffing.
• Avoid 483 and Warning Letters

Asked Questions:-

• What are your thoughts on user involvement in writing test cases? Is it appropriate for a user to both write and execute test cases?
• Do minor revisions need to be re-validated?
• Please explain more about the performance qualification - 10 steps of CSV?
• Definition of "Tester" in ISPE GAMP5 states that "testers should be as independent as possible. They should not be authors of the software, or of the test scripts if possible."
• Can you do a quick summary from start to finish from a manufacturer installing software on a device that a customer will be using perspective?
• Can we use a third party to perform the CSV instead of the user?
• You mentioned that Excel does not need to be validated. I understand that it depends on the Excel function. Can you please elaborate on that? Why do we not need to validate the Excel?
• Can we use automated testing scripts to validate? Such as Test Rails used by IT?
• Do you have recommendations for QA personnel to enforce CSV industry standard compliance, considering the laws/regulations do not include instructions for how to comply?
• Can you go over again why there is no traceability matrix needed for hazard analysis?
• Where does QA reside... in the IT department or the Quality department?

Why Should You Attend:-

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.

Who Will Benefit:-

• System owners - responsible for keeping individual systems in validation
• Computer system users
• QA / QC managers, executives, and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Consultants.