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Who should attend Seminar on Data Integrity - Beyond 21 CFR 11 & Annex 11
VP of IT, Directors and Senior Directors of IT, Discovery, Development, Commercialization, Quality Managers, Commercialization, Project Managers (for DATA INTEGRITY / IT), Validation Specialists, Database Administrators, System Administrators, Document Managers,Training Managers, Consultants, Data Managers, Safety Managers
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Seminar on Data Integrity - Beyond 21 CFR 11 & Annex 11  

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Global Compliance Panel   

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VP of IT, Directors and Senior Directors of IT, Discovery, Development, Commercialization, Quality Managers, Commercialization, Project Managers (for DATA INTEGRITY / IT), Validation Specialists, Database Administrators, System Administrators, Document Managers,Training Managers, Consultants, Data Managers, Safety Managers

Cost:   

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Seminar Summary:

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. (see full course description)

 
 

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Training Course Syllabus:


Data Integrity - Beyond 21 CFR 11 & Annex 11

Course "Data Integrity - Beyond 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 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 Assessment

Complete Validation for a System (software development lifecycle)

Automated Test Tools

Infrastructure Requirements

Change Control

SOPs

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.

Seminar Summary:

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. (see full course description)

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