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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 Wicked Wednesdays - Maintaining Spreadsheet Data Integrity for FDA Compliance

    • 15 May 2024
    • 5:00 PM - 6:30 PM
    • 45 Hayden Ave, Lexington, MA 02421
    • 26 registrants
    Register

    Maintaining Spreadsheet Data Integrity for FDA Compliance

    Joe Galletta & Andrew Knuepfer, CIMCON Software

    An overview of using spreadsheets in a compliant environment, and steps that can be taken to avoid FDA Form 483 Warning Letters. Some of the topics included are best practices for data integrity, and how to enhance data security/accountability of electronic GxP data.

    With 25 years of experience and 800 customers in 30 countries, CIMCON Software provides one-stop solutions for Compliant Digital Transformation™. CIMCON can bring your legacy lab/instrument software, Spreadsheets and Access databases into Part 11 compliance, while also automating critical business processes such as Spreadsheet Validation, Document Management, Training and Data Integrity Gap Assessments.

    Joe Galletta,  Director, Sales and Marketing

    Andrew Knuepfer, Sr. Sales and Marketing Manager

    The event will be hosted in person

    Takeda

    45 Hayden Ave, Lexington, MA

    A social networking event will follow with light snacks.


    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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