Interactive Workshops

Thursday, 4th September 2014

Workshop A: Opportunities and Challenges of Device Development

9:00am - 12:00pm

Plastic syringes have the advantages of being cheaper, have less oxygen permeability and fragility is not an issue, plastic as a syringe matieral has grown in popularity over the years. However, is there more we could be doing with the design features of a plastic syringe or even device?

This workshop will provide insight into plastic PFS and device development, attend to discuss:

  • The design possibilities of plastic syringes moulding
  • How novel plastic PFS features could impact device design
  • Ensuring the stability of biological drug products in plastic PFS
  • What material and component considerations do you need to apply to make your PFS a reality?

Join the PFS community at this workshop to discuss and debate novel and innovative possibilities for the future of PFS development


Wokshop Leader
John Zowtiak
Director, Device Development
Johnson & Johnson

John has extensive expertise in development and commercialization of drug delivery systems for pharmaceuticals. He is currently with Johnson & Johnson where he is the Director for Device Development.

Workshop B: Complying with Regulations: Human Factors Process

1:00pm - 4:00pm

The pressure from the FDA to conduct extra HF activities for combination products is becoming every more important. However, wih new updates and considerations and regulatory updates all the time, this has resulted in much confusion and uncertainty on how to conduct these activities successfully. 

This workshop will provide a guided tour on how to utilize human factors tools and ensure regulatory approval.

Attend this workshop to get to grips with:

  • Human factors process and how you can prepare to meet regulatory expectations
  • How you can use human factors process to identify device performance improvements
  • How usability assessments can be used to positvely influence regulatory approval

Have all your questions answered and leave this workshop with real life, hands on, practical experience to take back to the office on how to gain regulatroy approval for your product every time.


Workshop Leader
Ella Cozmi
Director, Human Factors, Engineering
Hospira

Ella is the Director of Human Factors Engineering at Hospira, Inc. She is a seasoned medical device developer with a background in nursing, physics and engineering. Ms Cozmi oversees the Human Factors program at Hospira, managing the specialty files for products ranging from prefilled syringes to infusion pumps. Prior to her curent position, she served as Manager, Medical Device Development at Hospira, as well as held positions of increasing responsibility at Abbot Laboratories. Ms Cozmi also serves on the Human Factors Committee at AAMI and occasionally contributes to the IEC Working Group 4 maintaining the IEC 62366:2007 Medical Devices - Application of Usability Engineering to Medical Devices. Ms Cozmi the author of several peer reviewed journal articles and regularly speaks at domestic and international conferences on the subject of Human Factors.