GEP: Risk and Cost Management

Effective project progress, monitoring, and control are not regulatory issues, but are necessary for the efficient operation of a company and part of Good Engineering Practice (GEP). This online course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEPs consisting of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations.

GEP underpins activities of daily operations and forward planning of a pharmaceutical business and the adoption of GEP methodology can lead to a balance of expenditure and activity. The scope of GEP covers the complete life cycle of engineering from concept to retirement and provides a foundation required across the pharmaceutical industry upon which other areas, such as GxP, build. In addition, GEP documentation can be leveraged to support verification work. This course also utilizes benchmarking tools from company practices against what is considered industry good practice.

Immediately apply the course learning objectives with an electronic download of the ISPE Good Practice Guide: Good Engineering Practice.

Attendance suggested for:

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

Course Modules/Learning Objectives

  • Module 1: Introduction, Philosophy, and Key Concepts
    • Define key concepts: project engineering, common practices, and operation and maintenance
    • Discuss the broad scope of GEP.
    • Describe Good Engineering Practices core concepts: risk management, cost management, and organization and control.
    • Discuss the principles of GEP.
  • Module 2: Project Engineering
    • Discuss project engineering including project infrastructure, project organization, value analysis, methods for planning and monitoring.
    • Identify the system for design review, construction, commissioning and qualification, and handover.
  • Module 3: Common Practices
    • Discuss standards and procedures.
    • Describe documentation practices used throughout the system.
    • Specify change management controls appropriate to assess.
    • Explain innovation and continuous improvement.
  • Module 4: Operations and Maintenance
    • Understand the activities required to sustain equipment and facilities using them for production purposes.

Petter Gallon, MSc, is CEO and founder of Gallon Partners. Currently he leads quality risk management and data integrity management efforts in major pharmaceutical companies. He is a popular speaker and tutor. As member of the ISPE Baseline® Guide authoring team, in the revision to the ISPE Commissioning & Qualification Baseline® Guide, he authored the Quality Risk Management part. He has played an important role as member of the steering team for the ISPE C&Q COP. He has 20 years of pharmaceutical and biopharmaceutical manufacturing experience as manager and specialist in the areas of process and packaging development, QA, validation and IS/automation, both globally and locally. He has led many successful projects and lean manufacturing initiatives.

Chris Derrett joined the pharmaceutical sector in 1989 after an early career in petrochemical process and automation engineering. He has been involved in a number of major projects for R & D, manufacturing facilities, new product development and general technical support around the world, mostly for central engineering and technical support groups for major pharma companies (Glaxo, Glaxo Welcome, GSK, Schering-Plough and Merck). Throughout his career he has supported ISPE, chairing the guidance document committee, managing the development of the GEP guide and supporting other work. After working in the USA for a number of years he has retired to UK in 2013, where he still supports ISPE and does a small amount of consultancy.


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