Basic Principles of Computerized Systems Compliance

Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-Based Approach to Compliant GxP Computerized Systems

This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.

GAMP was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.

Immediately apply the course learning objectives with an electronic download of the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide.

Course Modules/Learning Objectives

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  • Module 1: Regulations and Regulators
    • Review regulations relevant to computerized systems compliance.
    • Explain the concept of “GxP” Risk”.
    • Overview of the general principles of computerized system compliance and validation.
  • Module 2: Applying the GAMP® 5 Guide – An Overview
    • Explain the Scope and purpose of GAMP® 5.
    • Define the key structures and concepts of GAMP® 5.
    • Explain the key supporting processes of the project phase.
  • Module 3: Applying the GAMP® 5 Guide – Lifecycle Detail
    • Describe the five project stages.
    • Provide guidelines for conducting the audit.
    • Describe how the categorization of software and hardware components of a system can help define a life cycle strategy.
  • Review problems.
  • Module 4: GAMP® 5 – User Supplier Activities
    • Explain “good supplier practice”.
    • Understand the responsibility of a regulated company.
    • Illustrate the supplier assessment process.
  • Module 5: Quality Risk Management
    • Describe the systematic approach to Quality Risk Management.
    • Define Quality Risk Management according to ICH Q9.
    • Illustrate the five steps in the GAMP® 5 Quality Risk Management approach
  • Module 6: Testing
    • Describe the objectives of testing and the requirements for a test strategy.
    • Identify the different types of testing and their specifics.
    • Describe the GAMP® 5 approach to terminology.
  • Module 7: Operational Phase
    • Describe the structure of the Operational Phase in GAMP® 5.
    • Provide an overview of how guidance should be tailored and implemented within organizations.
  • Module 8: Efficient and Effective Compliance
    • Overview of the various efficiency improvements.
    • Discuss some of the areas where process efficiency improvements are possible.

Interactive Course includes:

  • A downloadable presentation for note-taking.
  • Engaging graphics.
  • Reference materials and links to regulatory information.
  • Assessments to measure your comprehension.
  • The ability to start and stop at any time, beginning where you left off.

CEUs are provided once you achieve an 80% passing grade and complete the evaluation.

Referenced Guide

GAMP 5 Guide: Compliant GxP Computerized Systems

Attendance suggested for

  • Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
  • Computer system vendors or consultants, engineering contractors, and validation service companies.

Instructor

 

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