Computer Systems Validation Conference 2018 – 21 CFR Part11 Compliance

Start Date : May 7, 2018
End Date : May 8, 2018
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : support@globalcompliancepanel.com

Location :
Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Website

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.


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:



  1. Validation Master Plan

  2. Complete Validation for a System

  3. Excel Spreadsheet Validation

  4. Change Control

  5. SOPs

  6. Test Tools Validation

  7. Project Management for Validation




Who Should Attend:





Industries:



Agenda:


Day 1 Schedule




Lecture 1:


Introduction / Background





Lecture 2:


Requirements at a High Level





Lecture 3:


Detailed Requirements Study





Lecture 4:


Design



Day 2 Schedule




Lecture 5:


CSV Detailed Study (Cont'd)





Lecture 6:


Other Documents





Lecture 7:


Special Topics





Lecture 8:


Change Control & Business Continuity



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.


 


Location:  Zurich, Switzerland Date: May 7th & 8th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland


Price:


 


Price: $1,895.00 (Seminar Fee for One Delegate)


Register for 5 attendees Price: $5,685.00 $9,475.00 You Save: $3,790.00 (40%)*


Register for 10 attendees Price: $10,422.00 $18,950.00 You Save: $8,528.00 (45%)*


Sponsorship Program benefits for “Computer Systems Validation Conference 2018 - 21 CFR Part11 Compliance” seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com  


support@globalcompliancepanel.com 


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901444SEMINAR?SEO


 


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Registration Info

Registration link :   http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901444SEMINAR?may-2018-seo-meetings4doc

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

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.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/


Event Categories: Business Practice and General Surgery.




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