GMP Fundamentals Bundle Series - Limited Offer

Operational Excellence in Pharma Operations Training Course

Effective and Efficient Deployment of Operational Excellence - Striving for World Class Performance in Pharmaceutical Operations (T56) - New Course!


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.

View Dates

What You Will Learn

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.

Resources and Activities

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

Course Module

  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.

Who Should Attend

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

Additional Course Details

Using the well-established architecture of the St. Gallen OPEX Benchmarking, this course also leverages this well-established industry-tested benchmarking approach. Additional content includes tools and techniques to help you identify appropriate solutions for specific problems to address issues in manufacturing and compliance.

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. 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.

Daily Schedule and Pricing

This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information