GAMP® 5 GxP Process Control Training Course

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

Overview

This highly interactive training course describes how the GAMP^® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems, may achieve process control systems that are fit for intended use and meet current regulatory requirements. This online course covers recommended good practice based on a lifecycle 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.

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What You Will Learn

• A comprehensive overview of current good practice for GxP regulated process control systems including data integrity
• Harmonized approaches for all types of process control systems
• Understanding of the process control system life cycle, and the data lifecycle
• 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/process understanding
• Effective collaboration between regulated companies and suppliers
• Leveraging of supplier activities
• Scalability of an approach based on GxP risk, GAMP categorization, and other factors
• 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

Resources and Activities

• Pre-Course Work Materials
• Interactive Exercises
• Learning Assessments
• ISPE 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

Who Should Attend

• Engineers who develop or maintain process control systems
• System owners and data owners for process control systems
• Quality assurance and quality control specialists
• Validation specialists
• Technical support personnel
• All levels of management who need a fundamental understanding of process control system compliance
• Computer system vendors or consultants
• Engineering contractors
• Validation service companies

Additional Course Details

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

Practical exercises using case study examples 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 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
• The degree of embedding of the computer system with the process equipment
• Interfaces introduced by phasing of delivery

Communities of Practice

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