The Power of Introducing TWI at Novartis PharmOps Stein

Presented By:

Christoph Bernoulli

 Session Abstract:

Engaging employees in training and to develop competences of the operational workforce is essential in a learning organization, but it isn’t easy. Novartis Pharmaceutical Operations in Stein is the center for new product launches and quality medicine on time every time for our worldwide patients.

In 2013 Novartis Pharmaceutical Operations in Stein identified the lack of an efficient and structured approach to train and develop operational workforce skills as well as the lack of basic process stability. It was decided by the site heads of the solid and sterile plant to start with individual TWI pilot projects.

In this presentation you will hear about two pilot projects and how to implement the TWI-JI approach in a regulatory environment.

The first TWI JI pilot project was started in the solids plant where are new production equipment was installed. The presenters will show the impact of the use of JI standardized training and you will learn about the approach to ensure and sustain the regulatory conformity of the trained processes.

In the second TWI JI pilot project started in the sterile manufacturing plant you will learn about the learnings and results from implementing JI standardized training for critical process steps as well as procedures with human errors in the past.

The presentation is about hands on experiences of implementing TWI JI in the pharmaceutical production and we invite you to join us and ask questions that will further inspire us on our TWI implementation journey.

Learning Objectives:

“In this session you will learn…”

  • Use of TWI JI in a regulatory environment
  • How to develop a responsive/learning training  system
  • Conscious following a standard
  • Pitfalls in a pilot project

About the Facilitator:

Christoph worked in Quality Assurance, Logistics and Manufacturing of pharmaceuticals for more than 6 years. He has gained experience in GMP training, manufacturing machine ramp-up’s as well as product transfers. His background in Neuroscience earned at EPFL and HMS enables him to understand the fundamentals of training. In his current role as operational excellence leader including certification as TWI JI and JR trainer, he pilots the TWI project in the sterile pharmaceutical product manufacturing with the passion to standardize and simplify procedures.