Computer System Validation

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Computer System Validation

Computer system validation helps in maintaining records and staying updated. CSV not only reduces regulatory risk, but it also increases understanding of the system during project implementation and enforces a structured, well-defined execution of the project. Pharmaceutical computer system validation is a unique opportunity for a business to examine its computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time.

Learning Objectives


  • Interpretation of past, present, and future changes to FDA guidance surrounding CSV.
  • Understanding of compliance with FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
  • The purpose of each validation deliverable and hands-on practice creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report.
  • Current CSV industry techniques and philosophies in the pharmaceutical marketplace for product quality and audit success.
  • Awareness of best-practices and inspector expectations for computer system validation and software quality assurance (SQA) programs.

Curriculum/Services

This course will be beneficial for anyone who involves himself/herself in FDA audits and Computer Systems Validation (CSV) on the global market. This course includes the following:

Lecture 1


  • 21 CFR 11-Electronic Records, Signatures –Basic Concepts.
  • Introduction/Background introductions/Participants Understanding.
  • Part 1: 21 CFR 11 & CSV – Basic Concepts.
  • Part 2: Computer Validation – an FDA Perspective.
  • Performance evaluation.




Lecture 2


  • CSV at a high level –Introduction and Applicability in Industry.
  • Part 1: CSV: It’s easy! Really!!
  • Part 2: CSV Components and deliverables.
  • Part 3: 21 CFR 11 Jeopardy!!!
  • Performance evaluation.




Lecture 3


  • Risk Assessment.
  • Part 1: Validation Plan.
  • Part 2: Requirements Specifications.
  • Part 3: Functional Specifications.
  • Part 4: Exercise on how to create requirements.
  • Performance evaluation.




Lecture 4


  • CSV Detailed Study (Cont’d)
  • Part 1: Functional & Design Specifications.
  • Part 2: Software Configuration and build exercise on how to create design specifications, periodic review report and inventory log.
  • Performance evaluation.




Lecture 5


  • CSV Detailed Study (Cont’d)
  • Part 1: SOPs.
  • Part 2: Traceability Matrix & Verification Testing.
  • Part 3: Exercise Creating Validation Scripts & Validation Scripts.
  • Part 4 : Validation Report & Validation Registry.
  • Performance evaluation.




Lecture 6


  • Continuous Medical Education.
  • Part 2: Regulatory Compliance for the Cloud.
  • Part 3: Implementing Business Continuity for CSV.
  • Performance evaluation.




Lecture 7


  • Part 1: Project Management for CSV.
  • Part 2: Selecting Software for 21 CFR 11 Compliance.
  • Performance evaluation.




Lecture 8


  • Vendor Audit.
  • Part 2: Change Management for CSV Projects.
  • Final assessments.




Requirements

The minimum eligibility criteria for the professional course in computer system validation would include either of the following:


  • Freshers and Experienced professionals in Engineering/Pharma/Medical/Biotechnology/or any other Science.
  • Experienced professionals in Pharmacovigilance / Clinical Trial Operations / Medical writing / Clinical data Management / Clinical SAS Programmers / Regulatory Affairs
  • IT, QA, & Business Managers and Professionals who need to:



    • Manage or participate in computer system projects requiring validation .

    • Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.

    • Understand the process of computer system validation.

    • Author, implement or upgrade CSV policies and procedures that utilize a risk-based approach to meet the latest regulatory expectations.

    • Understand the FDA and international regulatory landscape around CS.

If you are interested in Computer system validation, we are happy to assist you through the process.

Download the course pdf for a detailed understanding before you begin your Computer system validation Training with us!