The Association for GXP Excellence (AGXPE) is pleased to announce that our next in-person Mid-Atlantic Chapter meeting will be held at the Johnson & Johnson Innovative Medicine site in Titusville, NJ (1125 Trenton Harbourton Rd, Titusville, NJ 08560) on Friday, November 8th of 2024.
Check-In will begin at 10am and we will wrap up the event at 3:30pm. From 3:30pm - 5:30pm we will be hosting a social networking event nearby!
The agenda is as follows (all times in ET):
- 10:00 AM – 10:30 AM: Check-Ins, Registration
- 10:30 AM – 10:45 AM: Opening Remarks
- 10:45 AM – 11:00 AM: AGXPE Leadership Update
- 11:00 AM – 12:30 PM: "Quantitative Risk Management for better and defensible decision-making" - Julio Rivera (QMS Nexus)
- 12:30 PM – 1:30 PM: Lunch / Social
- 1:30 PM – 1:45 PM: Raffle (must be present to claim prize)
- 1:45 PM – 2:45 PM: "Risk-Based GxP Training Assessments: A Modern Approach" - Peter Alcocer (Veeva Systems)
- 2:45 PM – 3:30 PM: Open Forum/Closing Remarks
- 3:30 PM – 5:30 PM: Social Event (Location TBA)
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AGXPE Mid-Atlantic Chapter Food Drive
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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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Speaker Information/Bios
Julio Rivera: Founder & Global Integrative Lead, Audits, Risks & Compliance.
QMS Nexus
Mission: Reduce uncertainty to patients, compliance, and business aspirations. Integrate strategy, Internal Audit, with good global practices learned from ~30 country engagements. (coming soon).
Julio previously held roles as a lead in clinical manufacturing, quality lead for nuclear imaging API/sterile/devices, held diverse global audit, and regional CMO compliance roles. He has audited or overseen hundreds of CMOs, multinationals, internal sites, and business units on behalf of GSK (Vx,Rx,Cx) & Nycomed . He has hosted regulatory inspections & readiness, due diligences for acquisitions, supported consent decrees, assessed global audit programs, conducted numerous For Cause and Mock PAIs. Experiences include Fast Track Bio ADC, Phase I,II,II through PAI, Radiopharmaceuticals, ATMP, Bio-cell bank to fill, Sterile, Rx/Cx and Medical Devices. He led multiple enterprise assessments such as global cold chain, anti-counterfeiting, compounding, and CMO governance.
Peter Alcocer: Director of eLearning Compliance, Veeva LearnGxP
Veeva Systems
Peter is an experienced GxP professional with an extensive background in the Quality and GxP Training space. With 10 years of experience supporting Biotechs in the clinical, commercial, and CDMO space, Peter brings his industry knowledge to support LearnGxP's catalog of eLearning content through regulatory intelligence, thought leadership, and consultation strategy.
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Special thanks to Johnson & Johnson as the AGXPE MAC meeting host/sponsor for this event.
