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Validation and 21 CFR Part 11 Compliance of Computer Systems


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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

Details

The Problem

We have all heard of Computer Systems Validation & 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:

  • 21 CFR Part 11 and Computer Validation: Why so many citations?
  • Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
  • Data Integrity vs Computer Systems Validation
  • Overview and Key Requirements of Part 11 & CSV
  • How to use a Risk Based Assessment to reduce work while still achieving Compliance?
  • How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?

I often refer to 21 CFR 11 and CSV as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement CSV, it is 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 computer validation inspections and the number of citations on the subject are skyrocketing!

This course is appropriate for the beginner and the 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 21 CFR 11/Annex 11 and Computer Systems Validation 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. Equipment Qualification
  8. Infrastructure Requirements
  9. Change Control
  10. SOPs

Prices

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

Contact

John Robinson
globalcompliancepanel@gmail.com

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