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    Best Validation Practices for Laboratory Computer Systems Regulated by FDA

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    Website http://bit.ly/2r9k1XA | Want to Edit it Edit Freely

    Category 21 cfr compliance;21 cfr part 11 compliance

    Deadline: June 13, 2017 | Date: June 13, 2017

    Venue/Country: New York, U.S.A

    Updated: 2017-05-19 16:33:34 (GMT+9)

    Call For Papers - CFP

    Overview

    We will discuss the importance of applying industry best practices when validating laboratory systems that are regulated by FDA. Any “GxP” system (i.e., the system "touches" product during the laboratory testing or process) must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.

    This FDA Compliance course will describe the best practices for conducting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done.

    In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators.

    Why Should You Attend

    You should attend this webinar if you are responsible for planning, executing or validating a laboratory computer system, or managing the system in a validated state through the end of the system life cycle. The webinar will take you through the validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy.

    The webinar will cover the actual validation phases, deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation, while also making sure the approach is cost effective for your organization.

    All aspects of the work will be covered, including roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation. You will also learn what is required not only to validate your laboratory system, but also to maintain it in a validated state until it is retired or otherwise no longer in use.

    Areas Covered in this Webinar

    System Development Life Cycle (SDLC) Methodology

    Computer System Validation (CSV)

    Good “Variable” Practice (GxP)

    Good Manufacturing Practice (GMP)

    Good Laboratory Practice (GLP)

    GAMP 5 Guidance for System Classification

    Risk Assessment and Management

    Validation Strategy

    Change Control and Audit Trails

    User Requirements Specification (URS) & Functional

    Requirements Specification (FRS)

    System Design Specification (SDS) and System

    Configuration Specification (SCS)

    Test Planning, Execution and Documentation (IQ/OQ/PQ)

    Requirements Traceability Matrix (RTM)

    System Acceptance, Release Notification and Deployment

    System Retirement

    Data Governance Archival

    Learning Objectives

    Upon completion of this session, attendees will:

    understand laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework

    receive guidance on industry best practices necessary to develop an compliant and cost-effective validation program

    understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs

    have a good grasp of how to leverage best industry practices across all systems by creating a standardized computer system validation program

    Who Will Benefit

    Professionals in the following industries:

    Pharmaceutical

    Medical Diagnostics

    Biotechnology

    Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)

    Animal Health

    Professionals in the following subject areas:

    Information technology managers and analysts

    QC/QA managers and analysts

    Clinical data managers and scientists

    Compliance managers

    Lab managers and staff

    Automation analysts

    Computer system validation specialists

    GMP training specialists

    Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit

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

    For more detail please click on this below link:

    http://bit.ly/2r9k1XA

    Email: referralsatcomplianceglobal.us

    Toll Free: +1-844-746-4244

    Tel: +1-516-900-5515

    Fax: +1-516-900-5510


    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.