University of St.Gallen & ISPE Training Course 2017

Operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems and provides the pharmaceutical industry with a knowledge base to promote the use of best practices and operational excellence within pharmaceutical operations management. This course is designed to provide participants with a deep understanding of how to measure operational excellence including insights on relevant qualitative enablers as well as meaningful quantitative performance indicators.

Using the well-established architecture of the St. Gallen OPEX Benchmarking, the course leverages this well-established industry-tested benchmarking approach. The combination of enablers, quantitative performance indicators and structural factors will allow you to develop a manufacturing strategy or establish an operational excellence program to improve effectiveness and efficiency. The course also defines a common language with which to discuss operations management, and introduces lean concepts. Additional content includes tools and techniques to help you identify appropriate solutions for specific problems to address issues in manufacturing and compliance.

1. Review the principles of operations management and operational excellence
2. Understand the tools to assess current programs against objective measurements of best-in-class industry approaches and learn how to implement sustainable programs using real performance improvements and cost savings
3. Identify and develop industry good practices to:
   • Provide a reference, guidance, and support to pharmaceutical operations managers in selecting the most appropriate solutions for the identification and completion of the objectives of their manufacturing operations within the framework of their company organization, including external stakeholders and regulatory bodies
   • Provide operations management with a robust basis for understanding how compliance and continual improvement/innovation can be achieved simultaneously
   • Define a common language and provide guidance for performance measurement, benchmarking, and improvement
4. Review performance improvement tools (KPIs, TPM, TQM, JIT, EMS), clarifying what is applicable and what is not, for pharmaceutical operations
5. Know how to implement methods and tools for continual improvement

Professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those wishing to understand and implement the concepts of operational excellence.