The Association for GXP Excellence (AGXPE) is pleased to hold this in-person Mid-Atlantic Chapter meeting at the home facility of one of our sponsors, Merck, at the Upper Gwynedd Facility (351 N Sumneytown Pike, North Wales, PA 19454).
The agenda is as follows (all times in EDT):
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- 10:00AM – 10:30AM: Check-Ins, Registration
- 10:30AM – 10:45AM: Opening Remarks
- 10:45AM – 11:05PM: AGXPE Leadership Update
- 11:05AM – 11:20AM: Break
- 11:20AM – 12:10PM: GCP Clinical Auditing Using a Risk-Based Approach, Kelly Simpliciano – Director, Audit Management – BioNTech
- 12:10PM – 1:15PM: Lunch / Social
- 1:15PM – 1:30PM: Raffle (must be present to claim prize)
- 1:30PM – 2:20PM: Leveraging AI and Digitized Know-how for Achieving Operational Excellence in Industry 4.0, Sam Zheng – CEO & Co-Founder – DeepHow
- 2:20PM – 2:30PM: Break
- 2:30PM – 3:20PM: A Successful Data Management Quality Program, Becky Altmann – Director, Operational Excellence - Merck Research Laboratories
- 3:20PM – 3:30PM: Closing Remarks
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Community Give Back
AGXPE Mid-Atlantic Chapter Food Drive
In alignment with the AGXPE commitment to giving back to the communities where we operate, we will also be running a food drive at this event. AGXPE Mid-Atlantic Chapter Leadership will be collecting non-perishable food items for donation to Manna on Main Street, in Lansdale, PA.
Manna on Main Street operates a food pantry and soup kitchen, as well as provides other important services to neighbors in need, and is committed to ending hunger in the North Penn region. Any non-perishable goods (on this list) that could be dropped off at the event would be greatly appreciated and help out needy families in these challenging times.
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Presenters:
Kelly Simpliciano
Director Audit Management
BioNTech US Inc
Kelly Simpliciano has over 20 years of experience in auditing. Kelly obtained a B.S. from Rutgers University and her M.S. from Temple University in Quality Assurance and Regulatory Affairs. As Director of Audit Management at BioNTech, Kelly is currently responsible for the strategy and execution of the global development audit program which includes GCP, GVP, and GLP regulations. Previously Kelly worked at Bristol Myers Squibb for 20 years, and with roles of increasing level of responsibility in GCP and GxP IT auditing and compliance. Kelly’s audit experience includes clinical investigator sites, protocol level audits, partner audits, CROs, labs, technology vendors (imaging, eCOA, IRT, etc.), as well as many internal process audits. Additionally, she has supported multiple Health Authority inspections in various capacities.
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Sam Zheng
CEO and Co-Founder
DeepHow
Sam Zheng, CEO and Co-Founder of DeepHow, spearheads a rapidly evolving startup, backed by esteemed investors. DeepHow revolutionizes skilled workforce training with an innovative, AI-powered, video-centric knowledge capturing and transfer platform.
Prior to DeepHow, Sam dedicated over a decade to Siemens, driving digital innovation across various industries. His noteworthy projects, such as the Cloud Digital Inspection Jacket, have significantly improved technical knowledge sharing, efficiency, and user experience, earning his team the prestigious Siemens Innovation Award.
Simultaneously, Sam serves as an Adjunct Professor of Psychology at Tsinghua University and holds a Ph.D. in Engineering Psychology and a Master’s in Statistics from the University of Illinois at Urbana-Champaign.
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Becky Altmann
Director, Operational Excellence - Quality & Compliance Global Data Management & Standards
Merck Research Laboratories
Becky Altmann is a leader in research and pharmaceutical development with over 25 years of experience. She currently serves as the Director, of Operational Excellence - Quality & Compliance Global Data Management & Standards at Merck Research Laboratories where she has worked for the past 19 years. In this role, she leads and supports Quality and Compliance across GDMS. Becky is a Certified Project Management Professional and holds a BS in Veterinary Science and an MS in Biology Education. When Becky is not at work you can find her in her garden, hiking, beach combing, kayaking, or enjoying music with her husband.
