FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11
FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11
Combat the Misconceptions of 21 CFR 11 & Annex 11 - 2017
Course "FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11" 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 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:
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 Assessment
Complete Validation for a System (software development lifecycle)
Automated Test Tools
Infrastructure Requirements
Change Control
SOPs
Who will benefit:
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
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
SOPs
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
Speaker:
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.
Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.
More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Executive Education in Life Sciences and on the Stanford Who's Who Registry for contributions to the Lifescience industry.
Location: Zurich, Switzerland Date: April 19th & 20th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Zurich Airport
Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
Price:
Price: $1,695.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*
Until March 10, Early Bird Price: $1,695.00 From March 11 to April 17, Regular Price: $1,895.00
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