Validation and 21 CFR Part 11 Compliance of Computer Systems
Start Date: 2019-02-15
End Date: 2019-02-15
Time: 8:00 am to 11:00 am
Phone: (800) 447-9407
This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.
The attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems.
We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
- 21 CFR Part 11 and Computer Validation: Why so many citations?
- Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
- Data Integrity vs Computer Systems Validation
- Overview and Key Requirements of Part 11 & CSV
- How to use a Risk Based Assessment to reduce work while still achieving Compliance?
- How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
Why you should attend
This course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation.
Who Will Benefit
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for DATA INTEGRITY / IT)
- Validation Specialists
- Database Administrators
- System Administrators
Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.
About the Organizers :
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.
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