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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

  • Mind the Gaps: What Sponsors and CROs Aren’t Doing to Meet ICH E6 R3

    • 12 Feb 2026
    • 12:30 PM - 1:30 PM
    • Webinar
    Register

    Join us for a dynamic fireside-style chat exploring the critical gaps in how Sponsors and CROs are implementing the evolving requirements of ICH E6 R3. This 45–50 minute session will focus on three key areas—Risk-Based Approach (RBA), Quality by Design (QbD), and Computer Software Validation (CSV/CSA)—and uncover what’s being missed, misunderstood, or underutilized.

    Expect a candid conversation driven by two industry experts. The conversation will also be driven by audience input. We’ll dive into real-world challenges, share insights, and explore practical strategies for addressing ICH E6 R3. We are hoping for an interactive audience that will gauge where the industry stands and spark deeper discussion around these three key areas of the guidelines. Bring your questions and share how you are tackling the gaps.

    Presenter: Dawn Niccum, Executive Vice President of QA at inSeption Group


    Dawn is the Executive Vice President of QA at inSeption Group, where she is responsible for and does consulting in all quality areas including SOP development, Deviation & CAPA management, oversight of the implementation and validation for systems used in clinical trials, audit conduct and support, and GCP training. Dawn has worked in the pharmaceutical industry and with clinical trials for more than 30 years. Dawn is a Steering Committee Member for the CDISC TMF Reference Model, Chair of the Educational Governance Committee, and is a Steering Committee Liaison for the ISF Reference Model initiative. She has presented as an SME at numerous conferences on clinical quality systems and inspection readiness.

    Presenter: Marion Mays, CEO/Principal Consultant, Jerion Consulting Group


    Marion is a dynamic, inspirational leader in the Life Sciences space with over 30 years of experience. Focusing on supporting Clinical Trials, especially around clinical records, and compliance. Well known in the industry for experience with Inspection Readiness, a trusted advisor to sponsors in support of regulatory inspections and activities to become inspection prepared. Marion’s background offers a unique combination of both strategic and operational abilities combined with creative thinking. Marion’s experience working for sponsors, CROs, and software vendors makes her uniquely positioned to offer valuable insights into the Clinical Research compliance process and implementing software in a regulated environment.


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  • Creating a Learning Culture

    • 12 Feb 2026
    • 3:00 PM - 4:00 PM
    • Virtual Event
    • 22 registrants
    Register


    Register and join us for an interactive session with Kent Malmros, Vice President, Quality Strategy at Veeva Systems, focused on how organizations can intentionally build a strong learning culture.

    Explore the critical role culture plays in Learning and Development, hear real-world stories that bring culture to life, and gain a practical framework leaders can use to create a sustainable learning culture.

    Register now to learn from industry expertise and elevate learning across your organization.

    Speaker:  Kent Malmros

    Title/Company: Vice President, Quality Strategy / Veeva Systems


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  • Discussing the Undiscussables to Improve a Quality Culture

    • 16 Apr 2026
    • 2:00 PM - 4:00 PM
    • Virtual Event
    • 1 registrant
    Register


    Register and join us for an Interactive session to explore the impact of organizational dynamics and “elephants in the room” on the ability to establish a culture of quality and compliance.

    Discover the critical role culture plays in L&D, hear real stories that bring learning culture to life, and walk away with a practical framework leaders can use to build and sustain a thriving learning culture.

    Speaker:  Ed Francis

    Title/Company: Senior Principal, Accenture

    Bio: Ed Francis serves as Senior Principal in Accenture’s Thought Leader & Expert group, bringing more than 20 years of consulting experience across diverse industries. Ed specializes in organizational change and employee engagement, partnering with pharmaceutical manufacturers and supply chain organizations to drive improvements in quality manufacturing, commercial compliance, and data integrity. Based near Austin, Texas, Ed is passionate about helping teams achieve lasting impact through practical, people-centered strategies.
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  • Transformation Without Burnout: A People Centered Approach for the Era of Constant Change

    • 22 Jul 2026
    • 3:00 PM - 4:30 PM
    • Virtual Event
    • 3 registrants
    Register


    Register and join us for an Interactive session with real world examples of transformation missteps and successes. 

            Event Description: 

    Change initiatives in regulated industries often fail not because of poor intent, but because of training overload, unclear role impacts, and leadership behaviors that stop at go-live.

    In this interactive AGXPE session, participants will explore a practical, human-centered approach to change management that balances compliance with real-world adoption. Attendees will leave with tools, templates, and strategies they can immediately apply to improve change outcomes across Quality, Regulatory, and operational teams.


    Key Session Provisions:

    •  Practical change framework tailored to regulated industries
    • Language to align Qulaity, Learning and Transformation teams
    • Tools you can immediately use in their organization
    • Clear guidance on reducing training overload
    • Exploration of Change Management Systems 
    • Peer learning and shared challenges across GxP organizations


    Speaker Bio:

    Linda T. Cross is a senior leader in Organizational Change Management, Learning and Development, and Quality transformation with nearly two decades of experience across the pharmaceutical and life sciences industry. She has held progressive leadership roles at organizations including Takeda, Sanofi and Biogen, most recently serving as Director of Organizational Change Management for Global Regulatory Affairs at Takeda, where she led enterprise-wide transformation initiatives spanning regulatory modernization, system implementations, and operating model redesign. Linda is known for bridging change, learning, and compliance to drive real adoption in highly regulated environments, with a focus on reducing training overload and building scalable change systems. She is currently pursuing a Doctor of Education at Northeastern University with a research focus on human-centered learning and change systems in regulated organizations and serves as a leader within AGXPE, advancing practical, practitioner-led approaches to sustainable change.


    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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