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    Online Webinar :Maintaining Compliance of FDA-Regulated Computer Systems

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    Website http://c2gowebinars.com/product/?topic=maintaining-compliance-of-fdaregulated-computer-systems | Want to Edit it Edit Freely

    Category

    Deadline: June 16, 2016 | Date: June 16, 2016

    Venue/Country: Online, U.S.A

    Updated: 2016-05-03 16:57:12 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    "The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and have evolved over the last thirty years to align with changes in technology and best practices developed by industry, including the inclusion of risk assessment as a critical component of validation.

    Validation of computer systems in the regulatory environment must be a continuous rather than a discrete process. When auditing, regulatory agencies will expect you to have adequately planned and executed your computer system validation effort, and continue to maintain your system in a validated state."

    Why should you attend :

    Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.

    Applying best practices will ultimately result in minimizing the time and cost of regulatory audits, and the impact on operations and productivity. While there are many sources of information to help you develop a good validation program, this course will narrow down the most overall cost-effective approach that is tried and true.

    It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well. In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner."

    Areas Covered in the Session:

    This seminar will help you understand in detail the System Development Life Cycle (SDLC) Methodology and the importance of following this approach when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do as functionality and other changes occur over time. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

    Who will benefit: (Titles)

    Information Technology Analysts

    Information Technology Developers and Testers

    QC/QA Managers and Analysts

    Clinical Data Managers and Scientists

    Analytical Chemists

    Laboratory Managers

    Automation Analysts

    Computer System Validation Specialists

    GMP Training Specialists

    Business Stakeholders/Subject Matter Experts

    Business System/Application Testers

    This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.

    Webinar includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation

    Certificate of attendance

    For Registration : http://c2gowebinars.com/product/?topic=maintaining-compliance-of-fdaregulated-computer-systems

    Note: Use coupon code    and get 15% off on registration.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.