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WELCOME TO THE 

ASSOCIATION FOR GXP EXCELLENCE

The Association for GXP Excellence is turning nine (9) this year, with approximately 2000 active members and continues to grow and expand with  chapters in the Mid-Atlantic Area, San Francisco Bay Area and Boston.  We are continually seeking partnerships with other not-for profit associations and acquiring membership from groups that are having challenges surviving.  The organization is comprised of quality, compliance and training professionals throughout the world, in industry, academia and regulatory job roles.  We are a U.S Federally recognized 501 (C) 3, not-for-profit.  Our membership is free and open to all who wish to join.  Please click through our site to learn more about us and what we have in store for our membership as we rapidly grow!

The Association for GXP Excellence is turning nine (9) this year and continues to grow and expand with  chapters in San Francisco Bay Area and Boston.  We are continually seeking partnerships with other not-for profit associations and acquiring membership from groups that are having challenges surviving.  The organization is comprised of quality, compliance and training professionals throughout the world, in industry, academia and regulatory job roles.  We are a U.S Federally recognized 501 (C) 3, not-for-profit.  Our membership is free and open to all who wish to join.

  OUR MISSION IS SIMPLE

To develop and share scientifically sound, quality and compliance best practices coupled with practical technical training information and resources to advance quality and compliance training and compliance for, but not limited to, the pharmaceutical, biopharmaceutical, medical device, food, cosmetics and supplement industries through the expertise of our members. Learn More

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WHAT WE OFFER

Quality and Compliance

These are the pillars that our organizations require to invent, manufacture, store, release and ship to our customers. The AGXPE provides tools and resources to enable organizations to hit the ground running and maintain the pace!

Training

The knowledge ecosystem is by far the most diverse aspect of every organization. Hiring and maintaining individuals with specific Knowledge, Skills and/or abilities is paramount to success.  The AGXPE can help develop and maintain individual qualifications.

Membership

Members are mostly life science individuals working in regulated environments building quality into all aspects of their organization.  Become a part of something larger to network with others who seek to learn from each other.




Upcoming events

  • AGXPE 2024 Fall Mid-Atlantic Chapter Meeting (In-person)

    • 08 Nov 2024
    • 10:00 AM - 3:30 PM
    • 1125 Trenton Harbourton Rd, Titusville, NJ 08560
    Register

    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)

    ___________________

    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.

    ___________________


    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.

    ___________________


    Special thanks to Johnson & Johnson as the AGXPE MAC meeting host/sponsor for this event.


    Show details

Do you have a great presentation or story you would like to tell?

Just let us know and we will do our best to get your voice heard! You will receive accolades and name recognition!

The Association for GXP Excellence (AGXPE) is always looking for new and exciting presenters and topics for our meetings and webinars in the areas of Quality, Compliance and Training. 

Bring your best practices in GCP, GMP, GLP and other GXP areas and help educate us all

If you have what it takes please email agxpe15@gmail.com 

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