The 6 Most Common Problems in FDA Software Validation and Verification
120 Minutes
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
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.
AREA COVERED
- 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
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
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.
- 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
- 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
Speaker Profile
David Nettleton
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.
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