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    Webinar on FDA Compliance and Laboratory Computer System Validation

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    Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1828 | Edit Freely

    Category Food, Drugs & Biologics

    Deadline: July 27, 2106 | Date: July 27, 2106

    Venue/Country: Online, Canada

    Updated: 2016-06-30 18:47:08 (GMT+9)

    Call For Papers - CFP

    There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.

    Areas Covered in the Session :

    Gain an understanding of laboratory system computer validation planning, execution and management concepts

    Discuss the best practices for laboratory computer system validation that will ensure compliant results while minimizing costs

    Identify the GAMP 5 category for the system to understand how best to approach validation, particularly testing

    Discuss the key documentation associated with validating laboratory systems and maintaining them in a validated state, while minimizing costs

    Learn how to leverage these practices across all systems by creating a standardized program for FDA-regulated systems

    Understand the training that must be provided to business and IT staff involved in the validation process

    Discuss the business process re-engineering opportunities that might be leveraged as a system is implemented, particularly if it is more advanced than the legacy system in terms of technology and functionality

    Learn the advantage of incorporating a formal organizational change management system into the validation effort to ensure that users fully embrace the new technology and functionality

    Who Will Benefit:

    This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

    You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Professionals who will benefit include:

    Information Technology Analysts

    Information Technology Developers and Testers

    QC/QA Managers and Analysts

    Analytical Chemists

    Compliance and Audit Managers

    Laboratory Managers

    Automation Analysts

    Computer System Validation Specialists

    GMP Training Specialists

    Business Stakeholders/Subject Matter Experts

    Business System/Application Testers

    Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.


    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.