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 a 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 is 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:

1. What is Data Integrity 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. Automated Test Tools
8. Infrastructure Requirements
9. Change Control
10. 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/. The 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/2020/07/24/using-training-to-bring-compliance-to-boardrooms/ National Trainer for Society of Quality Assurance. Comments / collaborate 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, 2020 and Time: 9:00 AM to 6:00 PM
Venue: Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010, USA



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