ZebraSci is excited to announce that we will be at this year’s PreFilled Syringe Forum – Dec 07 – Dec 08, 2017 in sunny La Jolla, Ca. hosted by PharmaEd Resources.
The forum brings together industry and regulatory experts to share their experiences and explore new developments, regulatory considerations, trends and best practices.
Some of the Key Factors in Combination Product Development to be covered include:
• Regulatory Hurdles in Receiving PFS and Pen Approvals for Human Factors Studies
• Next Generation Materials & Design of Pre-Filled Syringes
• Improving Quality, Connectivity, and Cost Control in Combination Products & Autoinjectors
• Smart Devices: Their Emerging Role in Auto-Injector Systems
• Sterile Manufacturing of Injectables at CMO’s
• Managing the Materials used to Construct Pre-Filled Syringes
• Overcoming Complex Requirements for Biologic Drug Delivery
As part of the program, ZebraSci’s founder, Robert Schultheis will present on “Testing and Characterization needs for Combination Products” on Dec 08. The discussion will outline why the complete characterization of primary packaging, formulation, and device up front is essential to launching drug delivery / combination products in a timely fashion. Additionally, the presentation will show some of the variability that ZebraSci has encountered in root cause investigations and in combination product development programs.
ZebraSci works in partnership with our clients, working to ensure that their primary packaging and container systems meet existing and proposed regulatory requirements. With our network of resources, ZebraSci’s experienced team can help you select primary containers, establish device performance specifications, develop design verification testing plans and execute all the required testing. Our complaint handling and root cause analysis programs help you manage your device post-launch. Our consultation and highly-developed validation and qualification procedures, ensure that your device comes to market on time, on budget and in compliance with ISO 13485 and FDA 21 CFR 820.
Whether you’re interested in device engineering, regulatory, human factors or you’d just like to learn more about ZebraSci, let’s connect in La Jolla! Give us a call or email email@example.com to set-up a specific time to meet this December. From Concept to Commercialization – ZebraSci has you covered.
About Pharma Ed Resources and the Forum:
With the Pre-Filled Syringes market expected to top $16 billion dollars by 2021, the industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. Pharma Ed Resources, an industry leader since 2004, in delivering market-driven research on PFS, is proud to announce its 2017 Pre- Filled Syringes Forum. Pharma Ed brings together top scientists, regulatory experts and innovators to share best practices and the latest research in this field, enabling you to maximize your organization’s leverage in this dynamic and growing market.