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

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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