Events


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  1. IVT’s 2nd Annual Data Integrity Validation Conference

    August 17-18, 2016 Royal Sonesta Boston at Cambridge, MA

    Join us for IVT’s 2nd Annual Data Integrity Validation Conference to analyze the effects of FDA’s Data Integrity and Compliance with cGMP Draft Guidance released in April 2016 and implement enterprise-wide solutions.

    Don’t miss Ofni Systems’ President, Ty Mew speak on Auditing the Audit Trails – Key Elements to Define and Track your Data.

    Registration information for the 2nd Annual Data Integrity Validation Conference is available here.


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  2. IVT’s Paperless Validation & Document Management Conference

    August 17-18, 2016 Royal Sonesta Boston at Cambridge, MA

    Join us for IVT’s Paperless Validation & Document Management Conference to learn how to Implement FDA Compliant Procedures that Streamline Processes, Save Time and Reduce Cost.

    IVT’s premier Paperless Validation and Documentation Management conference is dedicated to overcoming the challenges of successfully developing, implementing and maintaining paperless validation processes within the validation environment.

    Validation practices have evolved significantly over the past 30 years and documentation has long been considered time-consuming, intensive and wasteful. Rapidly changing software, cloud-based applications, cyber security challenges, data integrity and ever-changing regulations are dramatically altering the ways in which we test and validate processes. Going paperless is the new frontier and will change the way we document and validate processes forever.

    Don’t miss Ofni Systems’ President, Ty Mew speak on Uncovering the Real Challenges of Validation and Discover the Benefits of going Paperless!

    Registration information for IVT’s Paperless Validation & Document Management Conference is available here.


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  3. IVT’s 17th Annual Computer and Software Validation

    April 26-28, 2016 Hilton at Penn’s Landing Philadelphia, PA

    Join us for the IVT’s 17th Annual Computer and Software Validation to ensure you implement the most current, compliant procedural trends in an ever-changing technology environment.

    Are you up-to-date with the most current CSV regulations and processes?

    With the strong regulatory focus from FDA and all other global authorities on data integrity, mobile medical devices, software apps, and cloud computing, it has never been more critical to understand up-to-the-minute regulations, trends and procedures involved with implementing CSV enterprise-wide.

    This is industry’s “must-attend” event for CSV validation, IT, engineering and QA professionals who are responsible for implementing and maintaining a best-in-class program.

    Write Better! Best Practices in Writing Specs and Test Protocols

    Registration information for the 17th Annual Computer and Software Validation conference is available .


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  4. Validation & GMP Week

    March 15-16, 2016 Sheraton Old San Juan Hotel, San Juan, Puerto Rico

    IVT’s Validation and GMP Week heads back to Puerto Rico! Join us to hear the latest regulatory updates and learn how to implement the best-in-class processes enterprise-wide.

    There is more going on in the validation and GMP environments than ever before. It has never been more critical to understand current regulations, trends and procedures such as statistics in validation, validating data and quality metrics. This conference covers the implementation procedures for equipment, utilities, cleaning, computer systems, analytical procedures, as well as other critical GMP topics such as change control, risk management and corrective action, enterprise-wide. Non-compliance and poor validation and GMP processes cost patient safety and efficacy, product time-to-market, personnel time and millions in fines and revenue. This is an event you don’t want to miss!

    Registration information for Validation & GMP Week is available .


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  5. 4th Global QA Conference & 30th SQA Annual Meeting

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    Tyson Mew, president of Ofni Systems, will be at the 4th Global QA Conference & 30th SQA Annual Meeting in Las Vegas, NV, from April 6–11, 2014. Ty will be demonstrating how ExcelSafe gives your analytical spreadsheets the controls and security features needed for 21 CFR Part 11 compliance.

    Learn how to Create and Validate Spreadsheets in FDA-Regulated Environments

    Easy-to-create and surprisingly powerful and flexible tools for data storage and processing, spreadsheets are so common that they can almost seem invisible. However, GxP data stored or processed with spreadsheets must be maintained in accordance with all applicable regulatory requirements, especially 21 CFR 11, Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets but expects controls to be in place that ensure spreadsheets used in GxP processes are compliant with 21 CFR 11 and are validated. As FDA enforcement of 21 CFR 11 increases, uncontrolled spreadsheets represent an area of increased QA concern.

    Society of Quality Assurance

    SQA’s 4th Global QA Conference & 30th Annual Meeting is a six-day conference for discussion of emerging trends and issues affecting Quality Assurance practices in regulated industry. Hot topics include Computer Validation, Scientific Archiving, Industry Best-Practices, and Compliance. The conference will feature a number of industry expert talks and opportunities for knowledge exchange among QA peers from around the globe.

    Ty Mew and Ofni Systems will be available throughout the conference to discuss spreadsheet and software compliance and validation.
    Registration information for the 14th Annual Computer and Software Validation conference is available .


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  6. ExcelSafe to Offer Integration with Sharepoint and Agilent Platforms

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    Raleigh North Carolina – Ofni Systems announces that the upcoming release of their ExcelSafe Spreadsheet compliance software application will offer support for enterprise-level document management systems including Microsoft Sharepoint and the Agilent OpenLab Enterprise Content Manager (ECM).

    “This is a giant step forward for the ExcelSafe application,” stated Ty Mew, President of Ofni Systems. “The next version will be a drop-in-place solution for both existing and new ExcelSafe customers that will offer the security, convenience, and document protection of a check-out/check-in module. Users can now travel with their spreadsheets while still maintaining full FDA 21 CFR Part 11 compliance.”

    The ExcelSafe software has been used at the FDA and by hundreds of pharmaceutical, medical device, and clinical companies to ensure that their spreadsheets are compliant with FDA regulations for electronic records and signatures. ExcelSafe allows these companies to use the flexibility and economy of spreadsheets to perform FDA regulated activities. ExcelSafe provides users of Microsoft Excel with:

    • User Security – Entry into spreadsheets requires a user name and password. ExcelSafe has configurable user-level security which can restrict which users can open or spreadsheets and apply or remove electronic signatures.
    • Data Security – All changes to Excel are automatically recorded. The audit trail records the previous and new value of a cell, the date/time of a change, the user making the change and the reason data was changed. The audit trail also records other spreadsheet events, including addition or deletion of a worksheet. Electronic signatures prevent changes within a worksheet. Even deleted records are preserved on an unalterable audit trail.
    • Traceability – ExcelSafe comes with tools to track all changes to spreadsheets. Users can query results from any spreadsheet.
    • Simplicity – ExcelSafe works automatically with existing spreadsheets and templates. Once a spreadsheet is opened in ExcelSafe, all compliance tools work automatically. Users operate Excel normally; there is no complicated interface to learn. ExcelSafe supports any number of users and any number of spreadsheets.

    More information about ExcelSafe is available at www.OfniSystems.com/ExcelSafe.

    About Ofni Systems

    Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.


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  7. Implications & Practical Advice from the Blood Establishment Computer Validation Guidance

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    When the FDA released the guidance for “Blood Establishment Computer Validation”, you probably logically thought it didn’t apply to you. While the focus of guidance is explicitly blood establishment computer systems, it represents the FDA’s current expectations for validation of high risk computer systems and includes some of the most explicit requirements released by the FDA for computer system validation. If you haven’t studied this document, you’ve missed a missed a thorough and pragmatic case study of FDA’s current expectations for computer validation of high impact computer systems. The guidance includes specific elements that should be included in validation procedures and cites specific methods and testing that should be performed on these systems.

    What You Will Learn

    • Specific validation testing cited in the guidance
    • Practices that should be included in your validation procedures
    • System documentation your organization should be maintaining
    • Expected validation deliverable content, including validation plans, risk assessments and validation reports
    • For enterprise level projects, which validation activities can be performed for the entire organization and which activities must be performed at each site
    • Validation activities the FDA expects after system changes

    On Wednesday, October 30 at 1:00pm EST, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about this new computer system validation guidance, including a discussion of the testing, system documentation, validation and change control procedures that your organization needs to have implemented to ensure compliance.

    About Ofni Systems

    Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.


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  8. 2013 PDA/FDA Joint Regulatory Conference

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    Tyson Mew, president of Ofni Systems, will be at the 2013 PDA/FDA Joint Regulatory Conference in Washington DC on September 16-18, 2013. Ty will be demonstrating FastVal, Ofni Systems’ validation management system that provides validation managers with the unique ability to control their validation process. Using FastVal allows your validation engineers to do more testing while reducing the time required to complete a validation project by up to 70%. Ty will also be demonstrating ExcelSafe, which provides MS Excel spreadsheets with audit trails, individual user passwords and all of the technological controls required for compliance with 21 CFR 11 and other FDA regulations for electronic records and signatures.

    The PDA/FDA Joint Regulatory Conference will provide FDA representatives and industry experts a forem to meet and discuss critical pharaceutical industry issues such as continual process validation, supplier management and quality oversite, supply chain and drug shortages and effective management of post inspection follow-ups. Parenteral Drug Association (PDA) is a global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community.

    Ty Mew and Ofni Systems will be available throughout the conference to discuss validation management, spreadsheet compliance and accept resumes from validation professionals.

    Registration information for the 2013 PDA/FDA Joint Regulatory Conference is available.


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  9. Part 11 Compliant Data Management: Doing it Right in the Real World

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    FDA requires your investigational drug or medical device data to comply with all of the provisions of 21 CFR Part 11. But how can you generate compliant, reliable data in today’s environment of fewer staff, a disappearing consulting budget and little time for training?

    Correctly managing drug or medical device data takes a variety of resources that sponsors, especially smaller firms, rarely have entirely in-house. But business has to run on a realistic budget. How can you balance the necessary requirements with the cost of compliance?

    A key tool to minimizing costs and regulatory risks is to find your data management resource gaps…and efficiently fill them.

    On Tuesday, April 2 at 1:00pm EDT, join FOI as Russell Barbare, Clinical Operations Manager with Ofni Systems, presents a 90-minute discussion of how to evaluate the skill sets you already have in place for drug or medical device data management – and how you can leverage this knowledge to identify and fill compliance gaps. You’ll hear practical advice on how to implement potential solutions and down-to-earth suggestions for maintaining necessary control in your clinical process.

    What You Will Learn

    • The skills you must have available to implement 21 CFR Part 11 and similar regulatory requirements
    • How to maintain control of your compliance
    • The areas most sponsors should probably outsource
    • Practical considerations when dealing with data management budgets
    • How to avoid often-overlooked compliance gaps that could damage your product development

    What You Will Get

    • A summary of many of the skills required to produce high quality data
    • Options for data management expenditures
    • Links or references to regulations and resources mentioned in the presentation
    • Practical advice from an instructor who has been involved in drug and medical device data management from preclinical work to final submissions
    • Time for questions and answers

    Who Should Attend

    • Clinical data management
    • Regulatory affairs
    • Quality assurance/quality control
    • Clinical software developers
    • Information technology
    • Executives providing input into data management
    • Staff who participate in data management hiring decisions

    To Register for this Conference

    Click here to register. For more information, or to register over the phone, call FOI Services at 800-654-1147 (+1-301-975-9400 outside the U.S. and Canada).

    About Your Instructor

    Russell Barbare has spent over decade of experience in clinical trial data management, first as a Data Management Specialist with Gad Consulting Services and subsequently moving to his current position as Clinical Operations Manager with Ofni Systems Inc. This experience has contributed to a large number of successful regulatory filings, covering aspects of development from INDs/IDEs to NDAs/PMAs. Russell has worked on virtually every aspect of clinical data management, including study data collection plans; site and lab auditing; database design and implementation; clinical data software design; regulatory compliance including 21 CFR Part 11 and GxP implementation; data cleaning and extraction; safety, efficacy, and pharmacokinetic analysis; report writing and regulatory submissions. If you would like to know more about the coverage of this presentation, you are invited to contact Russell directly at Russell.Barbare@ofnisystems.com.


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  10. Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets

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    Tyson Mew, president of Ofni Systems, will speak at IVT’s 14th Annual Computer and Software Validation conference in Philadelphia, PA, from April 17 through April 19. On Thursday April 18, 2013, Ty Mew will be a featured speaker, giving the presentation:  Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets.

    Learn how to Create and Validate Spreadsheets in FDA Regulated Environments

    Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common that they can almost seem invisible. However, GxP data stored within spreadsheets must be maintained in accordance with all applicable regulatory rules, especially 21 CFR 11; Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets, but expects controls to be in place to ensure that spreadsheets used in GxP processes are compliant with 21 CFR 11 and are validated. As FDA enforcement of 21 CFR 11 increases, uncontrolled spreadsheets represent an area of increased regulatory concern.

    Institute for Validation Technology

    IVT’s 14th Annual Computer and Software Validation conference is a three-day conference to discuss evolving computer and software validation practices. From the emergence of virtual networks, cloud computing and social media, the urgency of securing data integrity and complying with global regulations has never been greater. This conference aligns global regulations, best practices and case studies featuring the best CSV speakers to discuss developing, implementing and maintaining best validation practices in regulated environments.

    Ty Mew and Ofni Systems will be available throughout the conference to discuss validation.

    Registration information for the 14th Annual Computer and Software Validation conference is available.


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