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How TGA, FDA & Other Regulatory Authorities Inspect Computerized Systems fo...

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Sydney

Sydney, NSW 2000

Australia

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Refunds up to 30 days before event

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Description

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 manage 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

Learning Objectives:

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


For Registration - http://www.complianceonline.com/how-tga-fda-other-regulatory-authorities-inspect-computerized-systems-for-data-integrity-seminar-training-80501SEM-prdsm?channel=eventbrite

Note: Use coupon code REFERRAL10 and get 10% off on registration.

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Date and Time

Location

Sydney

Sydney, NSW 2000

Australia

View Map

Refund Policy

Refunds up to 30 days before event

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