Integrating Data Integrity within a Risk-Based approach to Compliant GxP Process Control Systems (T21)
Overview
This highly interactive classroom course describes how the ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition) , and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records may be applied to achieve process control systems that are fit for intended use, incorporate data integrity and meet current regulatory requirements. The 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. It looks at the data created by the process control system through the data lifecycle to understand how to protect against threats to data integrity. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.
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 to system functionality and data integrity
- Generation of accurate and complete user requirements with an early emphasis on product/process understanding and data flows
- Effective collaboration between regulated companies and suppliers
- Leveraging of supplier activities
- Scalability of approach based on GxP risk, GAMP categorization, threats to data integrity and other factors
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)
- GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
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 “hands-on” workshop 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
These are analyzed in terms of both process functionality and data integrity
Communities of Practice
This training course is of particular interest to existing and future members of the ISPE GAMP® Community of Practice (COP).