This 2-Hour Seminar 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.
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.
Why you should Attend:
Avoid the 6 most common problems associated with Part 11 and Annex 11 compliance. Learn how to efficiently create the specific documents required to implement data integrity requirements.Areas Covered in the Session:
- Which data and systems are subject to 21 CFR Part 11 and Annex 11
- Why data integrity 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
Speaker
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.Who Should Attend
- 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
