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Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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
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:
Who Should Attend:
Day 1 Schedule
Introduction / Background
Requirements at a High Level
Detailed Requirements Study
Day 2 Schedule
CSV Detailed Study (Cont'd)
Change Control & Business Continuity
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.
Location: Germany Date: May 3rd & 4th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price: $1,695.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,790.00 (40%)*
Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $8,528.00 (45%)*
Register now and save $200. (Early Bird)
Until March 31, Early Bird Price: $1,695.00 From April 01 to May 01, Regular Price: $1,895.00
Sponsorship Program benefits for “FDA 21 CFR Part 11 Compliance - Validation Seminar 2018” seminar
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