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Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T07)

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Level: Fundamental
ISPE CEUs: 1.3
Type: Classroom Training Course
Date Location Country Instructor(s)
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.

Description

This course is also available as an online training course, Basic Principles of Computerized Systems Compliance course.

This course has been updated to include the new revised EU GMP Annex 11, and an overview of 21 CFR Part 11.

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.

Immediately apply the course learning objectives using the complimentary copy of the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide.

Course topics include:

  • What are the FDA and EU regulatory requirements for GxP computerized systems?
  • Revised EU Annex 11 Computerized Systems, including the official GAMP interpretation of key aspects
  • FDA 21 CFR Part 11 Overview, including the current FDA interpretation
  • 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
  • Quality Risk Management for computerized systems
  • Practical Risk Assessment methods
  • 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
  • Pragmatic and efficient practices - cost effective compliance

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 Management and Detailed Risk
  • Testing
  • Operational Phases
  • Efficiency Improvements

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)

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

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.