Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

Start Date : December 7, 2017
End Date : December 8, 2017
Time : 9:00 am to6:00 pm

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

Location :
Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010, USA

Website

Description







 


 


Course "Data Integrity, 21 CFR 11 & Annex 11 Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


 


Overview:


 


The Problem:


We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:


Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News


Overview and Key Requirements of Part 11 & Annex 11


How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance?


How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?


I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the agencies have stepped up data integrity inspections and the number of citations on the subject are skyrocketing!


This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.


This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems


 


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:


What is Data Integrity and how is it implemented


How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?


Data Integrity Frequently Asked Questions


Validation Master Plan


Risk Based Asssessment


Complete Validation for a System (software development lifecycle)


Automated Test Tools


Infrastructure Requirements


Change Control


SOPs


 


Who Should Attend:


 


VP of IT


Director of IT


Quality Managers


Project Managers (for DATA INTEGRITY / 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


Consultants


Data Managers


Safety Managers


 


Agenda:


 


Day 1 Schedule


 


Lecture 1:


Introduction / Background


Introductions / Participants' Understanding


Participants' Objectives for the Course (Please come prepared to discuss)


Lecture 2:


Data Integrity


What is Data Integrity


How is it implemented


Data Integrity Frequently Asked Questions


Lecture 3:


21 CFR 11 & Annex 11


21 CFR 11


Annex 11


21 CFR 11.10(a) - Computer Systems Validation


Lecture 4:


Risk Assessment & Requirements


Risk Assessment for Requirements


Gathering Requirements


Entity Relationship Diagram


Process Decomposition


Exercise on how to create Requirements


 


Day 2 Schedule


 


Lecture 1:


Design


Design Specifications


Software Configuration and Build


Exercise on how to create Design Specifications


Lecture 2:


Verification & Testing


Traceability Matrix


Verification and Testing


Other Documents


Lecture 3:


Special Topics


Test Tools for DATA INTEGRITY


Infrastructure Requirements


Lecture 4:


Change Control & SOPs


Change Control


SOPs


 


Speaker


Angela Bazigos


CEO, Touchstone Technologies Silicon Valley



Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. 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/ National Trainer for Society of Quality Assurance. 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: SFO, CA Date:  December 7th & 8th, 2017 and Time: 9:00 AM to 6:00 PM


Venue:  Hilton San Francisco Airport Bayfront   600 Airport Blvd, Burlingame, CA 94010, USA


 


 Price:


Price: $1,495.00 (Seminar Fee for One Delegate)


Register for 5 attendees   Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*


Register for 10 attendees   Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*


Register now and save $200. (Early Bird)


 


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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NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com


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