Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.
This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools
The Seminar:
This hands-on 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 as follows:
- Validation Master Plan
- Complete Validation for a System
- Excel Spreadsheet Validation
- Change Control
- SOPs
- Test Tools Validation
- Project Management for Validation
Speaker
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.
Please fill in your name and email to receive the seminar agenda of this event.
Time: 9:00 AM to 6:00 PM
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
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Who Should Attend:
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for CSV / IT)
- Validation Specialists
- Database Administrators
- System Administrators
- Directors / Senior Directors of Discovery
- Directors / Senior Directors of Development
- Directors / Senior Directors of Commercialization
- Document Managers
- Training Managers
Industries:
- Pharmaceuticals
- Biotech
- Medical Device
- Radiological Health
- Blood Products
- Companion Animals
- Food
- Cosmetics
- Tobacco
- Academia
Venue
Venue to be confirmedGermany
