Combination product design and development, and the decision making surrounding these processes, is complex. Early collaborations between CDMO’s and their manufacturing partners is an effective means of managing this complexity. However, the best collaborations seek to develop a common understanding of program risks, technical risks, decision-making processes, who decision-makers are, a common language for the design and development, and a common vision for the program. These collaborations work to identify potential commercial manufacturing risks, and then address them during product development, to reduce overall risk during product launch. This effort maximizes the opportunity to successfully and efficiently manufacture combination products that are compliant with FDA 21 CFR, or other relevant regulatory standards, including 210/211 for drug handling. We will explore an effective collaborative model for combination design and development, and how we leverage this model to bring complex products, including combination products, to market in a timely manner, without sacrificing product quality.

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Speakers

Justin Westendorf, Product Development Manager, Phillips-Medisize

Justin Westendorf is a product development manager at Phillips-Medisize and has served in various engineering roles at Phillips-Medisize for over 20 years. Leveraging his experience and background in mechanical engineering, Justin leads cross-functional teams to efficiently design and develop products from conceptualization to commercialization by continuously evaluating usability, performance, and manufacturing.

Message Presenter

Brian Thompson, Director of Program Management, Phillips-Medisize

Brian Thompson is the director of program management at Phillips-Medisize, bringing over 15 years of expertise in the pharmaceutical industry to Phillips-Medisize. Thompson’s training as a chemist and in-depth knowledge of CMC (chemistry, manufacturing, and controls) product development augments the expertise of Phillips-Medisize’s engineers to bring forward the experience of our pharmaceutical partners early in the design and development process, and understand key hurdles to the manufacturing cycle, in order to quickly bring quality products to market.

Message Presenter

Who Should Attend?

This B2B webinar will appeal to managers and above at small-to-large pharma/medical device companies and job functions including but not limited to:

Pharmaceutical product developers in the injection and inhalation market
Pharmaceutical product managers
Pharmaceutical device engineers engaged in technology selection (R&D/Supply)
Pharmaceutical sustainability leads and supply chain managers (environmental)

What You Will Learn

This talk will highlight effective collaborative models for combination design and development, and how it can be leveraged to bring combination products to market quickly.

Xtalks Partner

Phillips-Medisize

Phillips-Medisize, LLC, a Molex company, is an end-to-end provider of innovation, development and manufacturing solutions to the pharmaceutical, diagnostics and medical device market segments. Backed by the combined global resources of Molex and its parent company Koch Industries, Phillips-Medisize’s core advantage is the knowledge of its people to integrate design, molding, electronics, and automation, providing innovative, high-quality manufacturing solutions.