7.30/10
Rating
Virtual Seminar United States California San Jose
Location
August 4 - 5, 2021
Date range
From 1499 USD
Pricing
See how this event performed in the previous years

Event details


Overview

Day 01(9:00 AM - 3:00 PM PDT)

  • Introduction to the FDA (1 hr)
    • How the regulations help your company to be successful
    • Which data and systems are subject to Part 11.
  • 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures (3:30 hr)
    • What Part 11 means to you, not just what it says in the regulations
    • Avoid 483 and Warning Letters
    • Explore the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, 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.
  • The Five Keys to COTS Computer System Validation (30 Min)
    • The Who, What, Where, When, and Why of CSV
  • The Validation Team (30 Min)
    • How to select team members
    • How to facilitate a validation project

Day 02(9:00 AM - 3:00 PM PDT)

  • Ten-Step Process for COTS Risk-Based Computer System Validation (1:30 hr)
    • 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).
  • How to Write Requirements and Specifications (30 Min)
    • Workshop for writing requirements and then expanding them for specifications
  • How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 Min)
    • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
  • Software Testing (1 hr)
    • Reduce testing by writing test cases that trace to elements of risk management.
    • How to write efficient test cases
  • How to write a Data Privacy Statement (30 Min)
    • How to meet the requirements of the EU GDPR
  • Purchasing COTS Software (30 Min)
    • How to purchase COTS software and evaluate software vendors
  • Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
    • How to save money
    • How to increase quality
    • How to increase compliance with less documentation

Speakers 1

#

David Nettleton

  • Computer System Validation
  • FDA Compliance Specialist

Organiser

Complianceonline

With an humble beginning in 2004, and a small directed effort, we started our journey to compile the world's first Compliance portal -- complianceonline.com. Go to event website »