The Computer System Validation training/webinar will have an interactive discussion of user validation as required by 21 CFR Part 11 and detailed recommendations for performing efficient validation projects.
Each of the keys is described in detail along with discussion of the real life common errors made today. The course concludes with detailed recommendations for performing efficient validation projects.
Areas Covered in the seminar:
- Who, What, Where, When, and Why of risk-based computer system validation?
- What to do right and how to avoid common errors?
- Selecting staff
- The role of IT
- Recommendations for successful projects
Who Will Benefit:
This session will benefit all computer system users:
- IT
- QA
- Managers
- Executives
Instructor Profile:
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 169 mission critical software validation projects.
