Date: | January 11, 2018 - 9:00am - January 12, 2018 - 6:00pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | BB, 80001, Germany |
Website for Event: | http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901447SE... |
Topic: | Seminars and Workshops |
Description: | 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. Overview: 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. 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: Who Should Attend: • VP of IT Industries: • Pharmaceuticals Agenda: Day 1 Schedule Lecture 1: Day 2 Schedule Lecture 5: Speaker: 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-brin.... 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: January 11th & 12th, 2018 and Time: 9:00 AM to 6:00 PM Price: Contact us today! NetZealous LLC DBA GlobalCompliancePanel Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=... Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ |
Contact Name: | Event Manager |
Contact Email: | john.robinson@globalcompliancepanel.com |
Contact Phone: | 800-447-9407 |