A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition) (T21)

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Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course





27 - 28 Sep 2016 Barcelona Spain Mrs. Hilary H. Mills-Baker
Mrs. Karen E. Ashworth
14 - 15 Nov 2016 Tampa, FL USA Mr. Michael Byrd


This highly interactive, course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a life cycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems, and the full system life cycle from concept to retirement.

The course shows how appropriate quality risk management and specification and verification activities should be an integral part of the normal system life cycle. Many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The course promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost and waste.

Practical “hands-on” workshop exercises using a wide range of case study examples across differing systems have been included to illustrate the approach covering a wide range of systems from basic equipment and instruments to large, complex, Distributed Control Systems.

The course concentrates on the following features of the system life cycle that are special, or particularly relevant to process control systems including multiple components and multiple suppliers; interfaces to a physical process being controlled in real time, to and degree of embedding with the process equipment and interfaces introduced by phasing of delivery.

Baseline Guide Cover Image Immediately apply the course objectives using the complimentary copy of the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition).

Course Modules

  • Key Concepts
    • Product and Process Understanding
    • Lifecycle Approaches and Categories
    • Scalable Activities
    • Risk Management
    • Leveraging Supplier Involvement
  • The Planning Stage
    • Risk Management
    • Approaches to Supplier Assessment
    • Validation Plan
    • Quality Plan
  • Specification Stage
    • Risk Management
    • Requirement Documentation and Traceability
  • Implementation Stage
    • Risk Management
    • Configuration Management
    • Coding and Code Reviews
  • Verification Stage
    • Test Principles
    • Writing a Test Script
    • Test Execution and Results
    • Recording
    • Test Incident Management
    • Test Review
    • Improving Efficiency
  • Reporting Stage
    • Risk Management
    • End User and Supplier Reports
  • Operation Phase
    • Repairs, Patches and Upgrades
  • Retirement
    • Data migration
  • ANSI/ISA-88
  • Process Analytical Technology

Take Back to Your Job

  • A comprehensive overview of current good practice for GxP regulated process control systems
  • Harmonized approaches for all types of process control systems
  • Understanding of the process control system life cycle, and discussion of the detailed engineering activities, covering:
    • Practical knowledge of applying the risk-based approach
    • Generation of accurate and complete user requirements with an early emphasis on product and process understanding
    • Effective collaboration between regulated companies and suppliers
    • Leveraging of supplier documentation
    • Scalability of approach based on GxP risk, GAMP categorization and other factors

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
  • 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 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.


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