What is Process Validation Report | 21CFR11 Compliance Checklist 2018

Start Date : January 11, 2018
End Date : January 12, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

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: Germany Date:  January 11th & 12th, 2018 and Time: 9:00 AM to 6:00 PM


Venue: WILL BE ANNOUNCED SOON , Germany


 


 Price:


Price: $1,695.00 (Seminar Fee for One Delegate)


Register now and save $200. (Early Bird)


Until December 15, Early Bird Price: $1,695.00 From December 16 to January 07, Regular Price: $1,895.00


Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*


Register for 10 attendees   Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*


Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar


At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.


As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.


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


 




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Registration Info

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support@globalcompliancepanel.com 

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Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

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