OVERVIEW

This webinar will take you through the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV), focusing on the definition, testing, and documentation of functional and other requirements to ensure the system meets FDA compliance.

This FDA compliance training will help you understand how the definition of functional and other system requirements fit into the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV). Getting the requirements right, and ensuring they are comprehensive, is one of the most challenging components of the process.

WHY SHOULD YOU ATTEND

You should attend this webinar to learn about:

• Computer System Validation (CSV) approach.

• Using the System Development Life Cycle (SDLC) methodology to support CSV efforts.

• CSV and SDLC deliverables that must be documented properly to comply with FDA requirements.

• A deeper dive into the Functional Requirements Specification (FRS) deliverable, a key document to support the CSV effort.

• Policies, procedures, training, and organizational change management that are all key aspects of a successful CSV effort and developing detailed and thorough requirements.

• Industry best practices related to CSV and the SDLC methodology, as well as for delivering solid requirements.

• Common findings of FDA related to CSV during computer system inspection and audit that can be avoided by following best practices to develop solid requirements as part of the effort.

AREAS COVERED

• Requirements for Computer System Validation (CSV) in compliance with FDA.

• Applying a strategic approach to CSV for FDA compliance.

• Using the System Development Life Cycle (SDLC) methodology to support CSV.

• CSV strategic planning, execution, and documentation.

• Detailed analysis of the Functional Requirements Specification (FRS), a key deliverable for the CSV effort.

• Policies and procedures to support the CSV effort and your requirements.

• Training and organizational change management best practices to support CSV and development of detailed and thorough requirements for testing.

• Preparing your computer system documentation for an FDA inspection.

• Q&A

LEARNING OBJECTIVES

• We will provide an overview of FDA’s guidelines as they pertain to computer system validation of GxP systems used in manufacturing, marketing, distribution and other operational activities engaged by companies in FDA-regulated industries.

• We will describe the System Development Life Cycle (SDLC) methodology and how to apply it to Computer System Validation (CSV) work.

• We will review the SDLC deliverables key to a successful CSV effort.

• We will take a deeper dive into the Functional Requirements Specification (FRS) process and documentation to support a successful CSV effort.

• This course will describe the best practices for developing detailed and thorough FDA system validation requirements, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.

• We will provide specific guidance on industry best practices for delivering solid requirements that will meet FDA compliance.

WHO WILL BENEFIT

This webinar will provide valuable assistance to all personnel in:

• Data “Owners”

• Data “Stewards”

• Information Technology Analysts

• Information Technology Developers and Testers

• QC/QA Managers and Analysts

• Clinical Data Managers and Scientists

• 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 the validation of computer systems.

For more detail please click on this below link:

 https://bit.ly/2Bn14r8

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