2017 ISPE Annual Meeting

Marriott Marquis

San Diego Marina

CA

San Diego

Join us at this leading industry event to gain new insights and network with industry peers.

You'll find NNE at booth no. 1510. Stop by to meet some of our global experts and get their perspectives on your current and future manufacturing challenges. Some of them will also be giving lectures as part of the conference programme.

Read about our speakers or go to the conference page to read more and sign up.

 

NNE speakers

Jeff Odum
WORKSHOP: Maximizing Manufacturing Utilization through Facility Design
Sunday, 29 October 1300 - 1515

Does continuous manufacturing equate to high manufacturing utilization? Is an underutilized manufacturing facility an economic and operational drag on an organization's bottom line? How do you define "high utilization" in manufacturing? Achieving optimal manufacturing utilization requires a deep understanding of product and process attributes, regulatory expectations, risk, operational platform approach, and facility integration around control strategy. The early steps in defining the manufacturing enterprise must address product type(s), current and new platform technologies, operational approach around infrastructure and support systems, and regulatory requirements. This session will explore current approaches to improving manufacturing utilization in biomanufacturing.

  


 

Henriette SchubertMonica Hueg
Personalised Medicines- Changing the Game of GMP and Commercial Manufacturing
Monday, 30 October 1100 - 1230

‘One-size fits all’ no longer applies to the world of pharmaceuticals. With the increased focus on new medicine applications, manufacturers pressure regulatory authorities for faster product approval. Regulatory authorities strive to evolve its regulatory processes in response to scientific developments. GMP compliance is essential to ensure the quality of medicinal products. The intrinsic characteristics of personalised medicine, such as oncology therapies include variability of the starting materials, small batch sizes, short shelf life, etc. These qualities pose specific challenges for the manufacturing process, operations and facilities.

This is when personalised medicine changes the healthcare industry game – not only in the way oncology diseases are treated, but also in the way medicine is developed, approved, produced and marketed. This paradigm creates challenges on how to make these therapies commercially viable and GMP compliant.

This presentation will discuss the GMP challenges versus sustainable commercial manufacturing.

 


 

Line Lundsberg-Nielsen
Implementing Pharma 4.0- The Holistic Manufacturing Control Strategy
Tuesday, 31 October 1045 - 1215

Understand how the Holistic Production Control Strategy as the key element for production execution is created out of the Control Strategy in development. We need the interdisciplinary collaboration of the different departments (QA/QC, Process Development, Manufacturing Operations, Engineering, Automation and IT) to design a robust and flexible production execution environment. Based on Best Practice case studies the enablers, elements and challenges of the Production Control Strategy implementation are discussed. The workshop will show the new opportunities in creating a best practice based methodology to create the Holistic Production Control Strategy. A well-designed Production Control Strategy is enabling Right First Time, Data Integrity and high performance best practice based processes. Participants will discuss and learn how to approach a Production Control Strategy implementation and its benefits when it is designed in a cross divisional approach.

 


 

Jeff Odum
Manufacturing Enterprise Facility Design
Tuesday, 31 October 1600 - 1630

In order to achieve operational excellence, a critical first step is to develop manufacturing facility design concepts and approaches focused on a manufacturing enterprise model. In this model, the process, facility, and infrastructure elements align with the product and process attributes and the control strategy to ensure that risk is identified and addressed in early Stage 1 design activities. This framework evaluates the Customer's requirements based on a sequence that efficiently creates the design basis for the facility to achieve the complex requirements of the manufacturing process. The framework must be straightforward, flexible, and efficiently guide the design process, focusing on the product attributes and the process unit operations over the enterprise's complete operating lifecycle required for manufacturing the product(s).

This session will describe this enterprise model and provide details on developing the key design elements, their relationship to the development of manufacturing strategy and achieving facility optimization, and identify key tools utilized to develop the enterprise framework. It will include case studies to look at the implementation of new enabling technologies, the focus on risk mitigation as part of an overall QRM approach, and address the critical impact of lackluster early-stage risk identification of project economic and execution stability.

 


 

Carsten Petersen
How to Execute the World Largest Biotech Project
Tuesday, 31 October 1600 - 1715

How do you execute one of the largest biotech projects in the world? How do you get it setup right? For successful and smooth execution?
Same could apply to an elephant. How do you eat an elephant?
The key here is to break it down into manageable/eatable sizes = Work Packages
Mr. Lohr will first introduce Novo Nordisk, the new API site in Clayton and how the new facility will look when fully build in 2020.
Mr. Petersen will then describe how the project is structured into Work Packages with Work Package Description for each sub component. How all schedules, cost, risk etc. is broken down according to the same structure to enable efficient execution of 50 sub-projects instead of one large project. The session also describes how all the Work Packages are coordinated via Interface Agreements and how some Work Packages have a more central and overall coordinating role!
In addition, the session will describe how the Project Management governance structure has been established and how the project team has been trained to all follow the same Project Management infrastructure (build on the principles known from PMI).