Events


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  1. 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets

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    Hundreds of 483’s and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements.

    In this webinar you will learn how to implement Part 11 requirements in databases (Access, Oracle, and SQL Server) and Excel spreadsheets.

    This presentation will provide the instructions, and documentation to ensure full compliance with 21 CFR Part 11, including:

    • Strategies for how to document and validate Access databases and other software applications based on databases.
    • How to add audit trails to databases and spreadsheets
    • How to define requirements quickly.
    • Managing change control and common change control mistakes to avoid.
    • How to document inputs, code and security settings.
    • How to properly secure the data and code.
    • Access security settings for multiple users.
    • Common settings applied to limit user actions.
    • Details on when and where to use electronic signatures.
    • Advanced techniques for adding electronic signatures
    • Inactivity timeouts, and controls for users and passwords.
    • Tips for efficient database testing.
    • Learn about how the FDA secures their own databases and spreadsheets

    e-Conference, Presented by the Executive Conference Corporation


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  2. How to Validate Device and Computer Software

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    Computer software validation has been a major issue for medical device manufacturers and is one of the leading causes of 483 observations, warning letters and product recalls. There are many different types of computer hardware and software found in the medical device industry, including:

    • COTS (Commercial Off-The-Shelf) applications
    • Custom in-house applications (databases and spreadsheets, web apps, etc)
    • Software embedded in medical devices
    • Software used to create or manufacture devices

    All of the above must be validated for intended use and be under strict change control.  The risk to patients can be severe for even small software bugs, and the cost of legal actions or product recalls can be financially devastating. The following topics will be covered in detail:

    • A review of recent enforcement actions as a result of inappropriate computer system validations.
    • The basics of computer software validation and what is expected in any validation effort.
    • A presentation of Ofni System’s methodology for how we create functional requirements, design specifications and test cases.
    • Education for users about specific hot spots, including Change Control and Risk Assessments.
    • A discussion of new technologies for automated testing and electronic protocol execution.

    e-Conference, Presented by the Clinical Device Group


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  3. How to Conduct a GAP Analysis of your CSV Program

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    Tyson Mew, president of Ofni Systems will speak at IVT’s 10th Annual Computer and Software Validation conference.

    Presented by IVT


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  4. 21 CFR Part 11 Compliance and Validation for MS Access Databases – 2/18/2009

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    Mr. Tyson Mew will address validation and 21 CFR 11 with regard to usage of Access databases. By properly securing your databases, you can allow a much wider audience to use and benefit from every database within the organization. The following topics will be covered in detail:

    • How to add audit trails to any part of the database
    • How to properly secure the data and code
    • Access database security settings for multiple users
    • Common settings to apply to limit user actions
    • Learn what the FDA will look for during audits
    • Managing change control and common mistakes to avoid
    • Details on when and where to use Electronic Signatures
    • Database testing and techniques for software validation

    Attendees will receive instructions for how to apply controls to their own access programs.  In additions, attendees may download sample code and validation documents for their own use.

    February 18, 2009
    e-Conference, Presented by the Clinical Device Group


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  5. How to Make Excel Part 11 Compliant

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    This conference addressed validation and part 11 with regard to your usage of Excel spreadsheets. You will learn what your options are and how to address the issues for the different categories of spreadsheets use. Tyson Mew will address:

    • What Excel is used for
    • Different categories of spreadsheets
    • Relevant regulations and history
    • Excel’s lack of compliance features
    • Where we are today with respect to Part 11 and enforcement
    • Options available to address Excel’s shortfalls
    • Applying those options to the different categories of spreadsheets
    • Managing the whole process
    • How to approach the issue if it’s an emergency and you have no money/time/resources

    e-Conference, Presented by the Clinical Device Group


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  6. Validation of Excel Spreadsheets in a Regulated Environment

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    Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District will give a presentation on “Validation of Excel Spreadsheets in a Regulated Environments.”

    Many lab decisions are being made based on the information in Excel spreadsheets. Excel spreadsheets can be as simple as a calculator or as complex as a custom made computerized solution. The use of this tool however might become a regulatory nightmare if they proliferate unchecked within any organization. The FDA is aware of the usefulness of Excel spreadsheets, but expects controls to be in place to avoid wrong decisions being made based on “on-the fly” worksheets that were created for one-time use. This session will address these concerns and offer strategies and approaches for response.

    A central part of this discussion will detail their experience using ExcelSafe with their regulatory spreadsheets. The FDA Office of Regulator Affairs, San Juan District is implementing ExcelSafe, Ofni Systems’ tool to provide audit trails, user level security, electronic signatures and other technological tools, allowing MS Excel spreadsheets to be compliant with 21 CFR 11. Ofni Systems President Tyson Mew will be available following the presentation to answer any questions about ExcelSafe and spreadsheet validation.

    Presented by Interphex


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  7. IVT Validation Week at the DoubleTree Hotel

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    FDA Validation Inspections and Latest Trends – FDA Validation Inspections and Latest Trends – The presentation will discuss FDA audit observations relating to validation. In particular, the presentation will examine why validation is consistently one of the most common observations reported in FDA audits and which types of validations generate warning letters. In particular, the presentation will focus on Computer System Validation, Equipment Validation and Cleaning Validation.

    Computer System Remediation & Validation for Regulatory Inspection – A Case Study – This presentation will outline a computer software validation compliance program. In particular, the presentation will demonstrate methods to generate validation documentation, and provide validation solutions for commonly used software like MS Access and MS Excel. The presentation will also include a validation case study review.

    Philadelphia, PA


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  8. Audio Seminar

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    Validation and Use of MS Access Databases in GxP and Part 11 Environments – Access databases are a simple way to meet many of the data collection and record keeping requirements required by the FDA but they also need to meet the technical requirements of 21 CFR Part 11, Electronic Records, Electronic Signatures. Out-of-the box Access has not been designed for regulated environments. This event will show you how to make Access databases Part 11 compliant.

    Order Recording


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  9. Validation and Use of MS Access Databases in GxP and Part 11 Environments

    “Validation and Use of MS Access Databases in GxP and Part 11 Environments”, hosted by Dr. Ludwig Huber and Lab Compliance.


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