Computer System Validation (CSV) for FDA-Regulated Computers

Date : 9th January 2019 to 9th January 2019

Place : United States, Aurora

Website :https://bit.ly/2PtXT56

Contact Person:Training Doyens

Description:

OVERVIEW FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with FDA system validation rules. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology. The webinar will leave you with the information needed for planning, executing and documenting a computer system validation effort that meets FDA compliance standards. You will learn about the computer system validation requirements and what must be done to ensure the system remains in a validated state. WHY SHOULD YOU ATTEND This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology 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. AREAS COVERED • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP)) • Validation Strategy that will take into account the system risk assessment process • Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way • System Design Specification (SDS) that details how the functional requirements will be delivered • Test Planning, including Development of Scenarios, Cases and Scripts (Installation Qualification, Operational Qualification and Performance Qualification) • Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements 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 for Computer System Validation. • To understand and avoid potential pitfalls. 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 For more detail please click on this below link: https://bit.ly/2SBwikz Email: [email protected] Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882

Computer System Validation (CSV) for FDA-Regulated Computers will be held in Aurora,United States on date 2019-01-09

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Deadline for abstracts/proposals : 9th January 2019

Keynote Speakers : 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.

Venue :Training Doyens, East Walker Drive, Aurora, CO, USA

Check the event website for more details.