Basic Principles of Computerized Systems Compliance (GAMP® 5) (T07)

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

Description

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.

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 lifecycle, Quality Risk Management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities.

Course topics include:

• What are the FDA and EU regulatory requirements for GxP computerized systems?
• How do investigators approach a computer systems inspection?
• Overview of GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
• GAMP system lifecycle and specifications - URS, FS, and design
• Key themes and concepts
• Quality Risk Management for computerized systems
• Computerized 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

This course was developed by members of the ISPE GAMP Community of Practice. GAMP was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.

Course Modules

• Regulatory Requirements
• Overview of GAMP 5
• User and Supplier Roles
• Quality Risk Mgmt. and Detailed Risk
• Testing
• Operational Phases
• Efficiency Improvements

Participants will receive a complimentary copy of the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide.

Take Back to Your Job

• Explain the regulatory requirements and expectations for computerized systems used in pharmaceutical manufacturing
• Apply GAMP principles to specific systems and cases
• Describe the GAMP approach to computerized system compliance
• Apply these ideas to systems within your own organization

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

Community of Practice (COP) www.ISPE.org/COPs

This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment and Production Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.