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Final Days to Register: 2 Day Interactive Risk-based Computer System Validation Course: Reduce Costs and Avoid 483 - October 4-5, 2022
Saturday, October 1, 2022

DUBLIN, Sept. 26, 2022 /PRNewswire/ -- The "Risk-based Computer System Validation; Reduce Costs and Avoid 483" training has been added to's offering.

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.

    --  It details the requirements for Part 11 and Annex 11: SOPs, software
        product features, infrastructure qualification, and validation.
    --  The instructor addresses the latest computer system industry standards
        for data security, data transfer, audit trails, electronic records and
        signatures, software validation, and computer system validation.
    --  Understand the specific requirements associated with local and
        SaaS/cloud hosting solutions.
    --  Nearly every computerized system used in laboratory, clinical,
        manufacturing settings and in the quality process has to be validated.
        Participants learn how to decrease software implementation times and
        lower costs using a 10-step risk-based approach to computer system
    --  The instructor reviews recent FDA inspection trends and discusses how to
        streamline document authoring, revision, review, and approval.
    --  Participants will learn how to write a Data Privacy Statement to comply
        with the EU General Data Protection Regulation (GDPR).
    --  This course benefits anyone that uses computer systems to perform their
        job functions and is ideal for professionals working in the health care,
        clinical trial, biopharmaceutical, and medical device sectors. It is
        essential for software vendors, auditors, and quality staff involved in
        GxP applications.

Learning Objectives:

    --  Reduce costs, usually by two-thirds, for compliance with electronic
    --  Learn how to use electronic records and electronic signatures to
        maximize productivity
    --  Understand what is expected in Part 11 and Annex 11 inspections so you
        are prepared
    --  Avoid 483 and Warning Letters
    --  Understand the responsibilities and specific duties of your staff
        including IT and QA
    --  Understand your responsibilities and liabilities when using SaaS/cloud
    --  Learn how to perform risk-based Computer System Validation using
        fill-in-the-blank templates
    --  How to select resources and manage validation projects
    --  "Right size" change control methods that allows quick and safe system
    --  Minimize validation documentation to reduce costs without increasing
        regulatory or business risk
    --  Learn how to reduce testing time and write test cases that trace to
        elements of risk management
    --  Learn how to comply with the requirements for data privacy
    --  Learn how to buy COTS software and qualify vendors
    --  Protect intellectual property and keep electronic records safe

Who will Benefit:

    --  GMP, GCP, GLP, regulatory professionals
    --  QA/QC
    --  IT
    --  Auditors
    --  Managers and directors
    --  Software vendors, SaaS hosting providers

Who Should Attend:

    --  GMP, GCP, GLP, regulatory professionals
    --  QA/QC
    --  IT
    --  Auditors
    --  Managers and directors
    --  Software vendors, SaaS hosting providers

Key Topics Covered:

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
    --  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
    --  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, 2006).
    --  How to Write Requirements and Specifications (30 Min)
    --  Workshop for writing requirements and then expanding them for
    --  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
    --  Software Testing (1 hr)
    --  Reduce testing by writing test cases that trace to elements of risk
    --  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

For more information about this training visit

Media Contact:

Research and Markets
Laura Wood, Senior Manager

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716


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SOURCE Research and Markets

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