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Housewarming and innovation sessions

Join NNE in US for this housewarming event in Durham to see our new office premises and pick brains with our experts at our innovation sessions.

 

Guests are free to attend as their schedule allow and sessions are open for all guests to chose. 

 

27 April 2017
1101 Slater Rd., Suite 120,
Durham, NC 27703, USA

Programme

11.30 am: Arrival

12:00-12:15 pm: Welcome and introduction by Søren Jelert, General Manager in US

12:15-1:00 pm: Free lunch and Coffee Station by Event Espresso Catering

1:15-2:00 pm: Session 1: Vendor innovation – new technologies in practice by Jeff Odum and Gilad Langer

1:15-2:00 pm: Session 1: Customer benefits of using BIM by Melody Wallace and E.J Alston

2:00-2:30 pm: Coffee break

2:30 – 3:15 pm: Session 2: Concurrent engineering - breaking down the silos by Gilad Langer and EJ Alston

2:30-3:15 pm: Session 2: Risk-based conceptual design delivery by Jeff Odum

3:30 pm: End of day

Session abstracts

Vendor Innovation - new technologies in practice
Technologies by themselves rarely provide a business advantage in a manufacturing setting. Manufacturing is inherently complex and therefore the use of technology typically is very complicated and risky. This is even more evident in a regulated environment where introduction of new technologies require extensive testing and robustness. That is why when evaluation new technological advances the benefits have to be evaluated based on a sound technology architecture that is rooted in the business drivers. With that in mind we can take a look at some very interesting innovations and technologies that with the right implementation can provide substantial business value.

Now we have to challenge our industry to take the leap to see if we can move the productivity, quality and flexibility needle.

Customer benefits of using building information modelling
The key principle is that BIM is not any single act or process. It is not creating a 3D model in isolation from others or utilizing computer-based fabrication. It is being aware of the information needs of others as you undertake your part of the process.

A BIM model can contain information/data on design, construction, logistics, operation, maintenance, budgets, schedules and much more. The information contained within BIM enables richer analysis than traditional processes. Information created in one phase can be passed to the next for further development and reuse.

Concurrent engineering – breaking down the silos
Engineering and design of a pharmaceutical facility requires extensive collaboration and communication between many engineering disciplines. Yet in the pharma industry, it is still common practice to engineer and design in disciplinary silos. This reduces the effectiveness of the project team due to silo communication, misalignment of deliverables\ approach, and lack of cohesiveness. Leading to increased cost and timelines.

Concurrent engineering sometimes also called Integrated Design presents a method in which engineering activities are performed in parallel with simultaneous activities leading to a higher quality process design and a more effective engineering process. The benefits include the ability to achieve specific design goals such as flexibility, decreased project timelines through parallel activities, integrated project quality, effective and efficient qualification, reduced project cost, and much more.

Risk-based conceptual design delivery
The regulatory focus of facilities that manufacture therapeutic products for humans is centered on a product-process-facility attribute driven methodology where risk identification and mitigation are critical quality attributes. Under this methodology, the manufacturing process and the product requirements, not the building, become not only the main drivers for CD efforts, but must also provide a clear approach and understanding of how the building elements must be defined and operated in order to ensure patient safety in the manufacture of the product. This requires an enterprise approach to facility design focusing on:

  • Process-driven understanding around operational analysis
  • Regulatory philosophy
  • Business drivers
  • Management needs
  • Integrated handoff to detailed design activities
RSVP for the Housewarming

EJ Alston

EJ is a manufacturing manager with over 13 years of engineering and manufacturing management experience - including 8 years in the pharma/biotech industry. He has applied solid knowledge of regulatory guidelines and engineering skills to fill finish manufacturing in several projects and has successfully executed multiple technology and product transfers from scale up to commercialization.

He authored sections of the biologics license application (BLA) and participated as subject matter expert (SME) for pre-approval inspection (PAI). With a background in process engineer, EJ is knowledgeable within formulation, filling, packaging and autoclave equipment installation, optimization and validation.

Melody Wallace

Melody is a project manager with more 20 years of experience in the life sciences industries, with projects ranging from $2 million to over $17 million. Her strengths include coordination within project teams to include: owners, designers/engineers, vendors, contractors and authorities having jurisdiction. She is also highly skilled at tracking and managing project financials and schedules.

Melody has worked closely with clients and design teams as the project manager to create a partnership that supports the project execution and ensure joint cooperation to achieve the project objective.