2018 - Validation and 21 CFR Part 11 Compliance of Computer Systems

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.
Description:
The Problem
We have all heard of Computer Systems Validation & 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:
• 21 CFR Part 11 and Computer Validation: Why so many citations?
• Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
• Data Integrity vs Computer Systems Validation
• Overview and Key Requirements of Part 11 & CSV
• How to use a Risk Based Assessment to reduce work while still achieving Compliance?
• How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
I often refer to 21 CFR 11 and CSV as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement CSV, it is 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 computer validation inspections and the number of citations on the subject are skyrocketing!
This course is appropriate for the beginner and the 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.
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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. What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented
2. How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
3. Data Integrity Frequently Asked Questions
4. Validation Master Plan
5. Risk Based Assessment
6. Complete Validation for a System (software development lifecycle)
7. Equipment Qualification
8. Infrastructure Requirements
9. Change Control
10. SOPs
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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
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Industries:
• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Hospitals
• Healthcare
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia
• Agricultural
Agenda:
Lecture 1:
21 CFR 11 & Annex 11
• Introductions / Participants' Understanding
• Participants' Objectives for the Course (Please come prepared to discuss)
• 21 CFR 11 / Annex 11
• 21 CFR 11.10(a) - Computer Systems Validation
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Lecture 2:
Data Integrity
• What is Data Integrity
• How does it fit with 21 CFR 11
• FDA's latest guidance
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Lecture 3:
Risk Assessment & Vendor Audits
• Vendor Audits
• Risk Assessment for the System
• Risk Assessment for Requirements
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Lecture 4:
Requirements
• Gathering Requirements
• Entity Relationship Diagram
• Process Decomposition
• Exercise on how to create Requirements
Day 2 Schedule
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Lecture 5:
Design
• Design Specifications
• Software Configuration and Build
• Exercise on how to create Design Specifications
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Lecture 6:
Verification & Testing
• Traceability Matrix
• Verification and Testing
• Other Documents
• Exercise to create Test Cases
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Lecture 7:
Special Topics
• Equipment Qualification
• Infrastructure Requirements
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Lecture 8:
Change Control & SOPs
• Change Control
• SOPs
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Lecture 6:
Conclusions / Wrap-Up
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/4FA562336EBD46C58C... 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/... 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.7144....
Location: Philadelphia, PA Date: October 4th & 5th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153
Price:
Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Register now and save $200. (Early Bird)
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