FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11

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:

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 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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