Basic Principles of Computerised Systems Compliance
Applying the GAMP®5 Guide A Risk-based Approach to Compliant GXP Computerised Systems

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Milan, 6-7 October 2008

Basic Level
ISPE CEUs*: 1.3
Type: Classroom Training Course

Instructor: Sion Wyn, Conformity Ltd. (UK)

Description
This basic course introduces participants to regulatory requirements for computerised systems in the pharmaceutical industry and explores tried, tested, and internationally recognised methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerised systems that are fit for intended use and meet current regulatoryrequirements, by building upon existing industry good practice in an efficient and effective manner. The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system life cycle, quality risk management applying ICH Q9, updated GAMP® categories, supplier assessment, and the selection of appropriate specification and verification activities.

Classroom Objectives
  • What are the FDA and EU regulatory requirements for GxP computerised systems?
  • How do investigators approach a computer systems inspection?
  • Overview of GAMP®5 Guide: A Risk-based Approach to Compliant GxP Computerised Systems
  • GAMP system life cycle and specifications - URS, FS, and design
  • Key themes and concepts
  • Quality risk management for computerised systems
  • Computerised system validation framework - plans and reports
  • Risk assessment method
  • Scalable specification and verification based on risk
  • Updated GAMP categories
  • Role of users and suppliers – assessment and cooperation and leveraging supplier activities and documentation
  • Testing in GAMP - principles and practical approaches
  • Verification approaches and qualification terminology and concepts
  • Policies, procedures, and plans required for effective governance
  • Pragmatic and efficient practices - cost-effective compliance
  • New special interest topics, including control of spreadsheets and end-user databases
  • Operation, control, and maintenance of systems

Take Back to Your Job
  • Explain the regulatory requirements and expectations for computerised systems used in pharmaceutical manufacturing
  • Apply GAMP principles to specific systems and cases
  • Describe the GAMP approach to computerised system compliance
  • Apply these ideas to systems within your own organisation

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 computerised system compliance and regulations
  • Computer system vendors or consultants, engineering contractors, and validation service companies
  • This Training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP)

Important Course Notes
  • Participants will receive a complimentary copy of the GAMP®5 Guide: A Risk-based Approach to Compliant GxP Computerised Systems.
  • This course was developed by members of the ISPE GAMP Community of Practice (COP). GAMP was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerised systems in pharmaceutical manufacturing.
  • This course contains knowledge related to the CPIPSM technical knowledge competency element Facilities and Equipment. For complete information concerning the knowledge elements or the CPIPSM Credential, please visit www.ISPE-PCC.org.