FDA Data Integrity for Computerized Systems Combat the Misconceptions of 21 CFR 11 and Annex 11

FDA Data Integrity for Computerized Systems Combat the Misconceptions of 21 CFR 11 and Annex 11

 

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About The Event

Agenda:

 

Day One


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 Two


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