$989 – $4,589

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

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Sydney

Sydney, Sydney 2000

Australia

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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!

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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


Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • 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 02(8:30 AM - 4:30 PM)
  • 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


    Angela Bazigos

    Angela Bazigos
    CEO, Touchstone Technologies Silicon Valley

    Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

    Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

    More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.


    Please contact the event manager Marilyn below for the following:
    - Discounts for registering 5 or more participants.
    - If you company requires a price quotation.
    Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
    You can also contact us if you require a visa invitation letter, after ticket purchase.
    We can also provide a certificate of completion for this event if required.

    NO REFUNDS ALLOWED ON REGISTRATIONS
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Sydney, Sydney 2000

Australia

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Refund Policy

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