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Basic Principles of Computerized Systems Compliance: Applyin
Basic Principles of Computerized Systems Compliance: Applyin
Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
This fundamental 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

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
  • Identify the specification and verification approach
Module 3: Applying the GAMP® 5 Guide – Lifecycle Detail

  • Describe the five project stages
  • Explain the key supporting processes of the project phase
  • Describe how the categorization of software and hardware components of a system can help define a life cycle strategy
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
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 Biography

Sion Wyn is an acknowledged expert in computer system validation and compliance and international regulations in this field. He assisted the FDA with its re-examination of 21 CFR Part 11, and is a member of the team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He is the technical content expert for the FDA's ORA Virtual University on-line training modules on computerized systems validation and compliance. He has received the FDA Group Recognition Award for work on Part 11.
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