2026-September ASQ Orange Empire, Section 0701, Monthly Meeting- Sept. 8th
About this Event
Monthly Meeting Agenda:
5:30 - 6:00 PM Registration
6:00 - 6:15 PM Section Updates & Awards
6:15 - 7:15 PM Clinic-1
7:15 - 7:45 PM Dinner
7:45 - 8:45 PM Clinic-2
8:45 - Networking
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CLINIC - 1
Topic: “Exploring the Future of Parenteral Combination Products”
Presented by: James Wabby
SYNOPSIS:
Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products for will require great collaboration within the industry to overcome regulatory, clinical and technical challenges.
SPEAKER BIO:
James Wabby is Vice President, Head of Regulatory Strategy (CoE) for Combination Products and Emerging Medical Technologies, and a Volwiler Senior Research Industry Fellow in Regulatory Science at AbbVie Inc. He brings over 25 years of global regulatory affairs and quality compliance experience across biopharmaceuticals, medical devices, and digital health.
An internationally recognized thought leader, Mr. Wabby is an Adjunct Assistant Professor at the University of Southern California (USC) and serves as Chairman of the Combination Products Committees for both DIA and ISPE.
He holds a BSc in Molecular Biology and an MHMS in Health Law and Policy from Duquesne University, a Life Science Regulatory Compliance Certificate from Seton Hall University Law School, and completed the RAPS Executive Development Program at Kellogg School of Management. He is currently a DRSc Candidate in Regulatory Science at USC (Expected 2027)..
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CLINIC - 2
Topic: “Digital Transformation in Pharmaceutical Industry”
Presented by: Jamie Tom
SYNOPSIS:
The Pharmaceutical industry is undergoing revolutionary changes enabled by automation and innovative technologies. One aspect is digital transformation, Pharm 4.0, originally coined by the International Society for Pharmaceutical Engineering (ISPE). It is the pharmaceutical adaptation of Industry 4.0, representing the convergence of digital technologies, automation, and data analytics to create smart manufacturing environments. In this session, the key principles, benefits, and challenges will be discussed. Gain practical insights into how to develop and apply digital transformation in your own workplace.
SPEAKER BIO:
Jamie Tom is a seasoned Quality Professional with more than three decades of leadership in biotechnology and cell therapy, Jamie Tom is well-versed in Quality and drug development. She has demonstrated mastery across the development pipeline, from proof of concept through FIH, and commercial QC testing. Having operated as a sponsor managing contract organizations, a contract manufacturer serving clients, and a consultant, she possesses a unique 360-degree perspective on the industry. Currently, she serves as a lecturer at Cal Poly Pomona, training the next generation of industry professionals.
Where is it happening?
Event Location & Nearby Stays:
USD 30.00 to USD 40.00
