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    In-Depth Testing of Computer Systems Regulated by FDA

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    Website http://bit.ly/2zJvAtvhttp://bit.ly/2zJvAtv | Want to Edit it Edit Freely

    Category LIfe Science

    Deadline: November 28, 2017 | Date: November 28, 2017

    Venue/Country: Training Doyens 26468 E Walker Dr,Aurora, Colora, U.S.A

    Updated: 2017-11-15 15:37:23 (GMT+9)

    Call For Papers - CFP

    OVERVIEW

    This FDA compliance webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process.

    FDA requires that all documentation related to GxP (GMP, GLC, and GCP) products be created and maintained in accordance with specific rules. From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation.

    WHY SHOULD YOU ATTEND

    You should attend this webinar if you are responsible for any FDA-regulated data and/or records. All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit. You will also benefit from learning about the guidelines for computer system validation and the many deliverable documents that need to be produced in a way that is FDA-compliant. Having completed this course, you will be on your way to successful future FDA audits and inspections.

    AREAS COVERED

    FDA Good Documentation Practices

    Computer System Validation (CSV)

    System Development Life Cycle (SDLC) Methodology

    GAMPV System Categorization

    Industry Best Practices

    Potential Pitfalls

    Q&A

    WHO WILL BENEFIT

    Information Technology Analysts

    QC/QA Managers

    QC/QA Analysts

    Clinical Data Managers

    Clinical Data Scientists

    Analytical Chemists

    Compliance Managers

    Laboratory Managers

    Automation Analysts

    Manufacturing Managers

    Manufacturing Supervisors

    Supply Chain Specialists

    Computer System Validation Specialists

    GMP Training Specialists

    Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit

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

    Auditors engaged in the internal inspection of labeling records and practices

    All FDA-regulated industries:

    Pharmaceutical

    Biologicals

    Medical Device

    Tobacco

    LEARNING OBJECTIVES

    To understand how to create, revise and maintain documentation that is FDA-regulated.

    To understand the many deliverables required to complete a computer system validation effort.

    To understand industry best practices.

    To understand and avoid potential pitfalls.

    SPEAKER

    Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

    During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

    Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

    For more details click on this link:

    http://bit.ly/2zJvAtv


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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