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Overview:

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
Many companies are outsourcing IT resources and getting inv

21 CFR Part 11 compliance for software validation and SaaS/Cloud

 

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About The Event

Agenda:


Day One


Lecture 1:

Introduction to the FDA

  • How the regulations help your company to be successful
  • Which data and systems are subject to Part 11

Lecture 2:

21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures

  • What Part 11 means to you, not just what it says in the regulations
  • Avoid 483 and Warning Letters
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
  • How SaaS/cloud computing changes qualification and validation
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Lecture 3:

The Five Keys to COTS Computer System Validation

  • The Who, What, Where, When, and Why of CSV

Day Two

Lecture 1:

Ten-Step Process for COTS Risk-Based Computer System Validation

  • Learn which documents the FDA expects to audit.
  • How to use the risk-based validation approach to lower costs.
  • How to link requirements, specifications, risk management, and testing.
  • Document a computer system validation project using easy to understand fill-in-the-blank templates.
  • Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Lecture 2:

How to Write Requirements and Specifications

  • Workshop for writing requirements and then expanding them for specifications

Lecture 3:

How to Conduct a Hazard Analysis/Risk Assessment-Exercise

  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

Lecture 4:

Software Testing

  • Reduce testing by writing test cases that trace to elements of risk management.
  • How to write efficient test cases

Lecture 5:

System Change Control

  • How to manage a validated system with minimal documentation

Lecture 6:

Purchasing COTS Software

  • How to purchase COTS software and evaluate software vendors.

Lecture 7:

Cost Reduction Without Increasing Regulatory or Business Risk

  • How to save money
  • How to increase quality
  • How to increase compliance with less documentation

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