WELCOME TO THE 

ASSOCIATION FOR GXP EXCELLENCE

The Association for GXP Excellence is turning 5 this year and continues to grow and expand with new chapters coming online in San Francisco Bay Area and Boston.  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!

  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.

NOT A MEMBER YET? 

JOIN US







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

    • 16 Jun 2021
    • 3:00 PM - 4:45 PM (EDT)
    • Online
    Register



    The New England AGXPE Chapter Presents: 

    COVID Next Phase: implications for Biotech and the GxP Landscape

    Agenda

    • Speaker Presentation 3:00 PM-4:00 PM
    • Recruiter Connect Session 4:00 PM-4:45 PM - Bring your resume!

      Recruiters from Advanced Instruments LLC & Takeda will be in attendance for the connect session.

    Come and discuss the impact of COVID on the bio-tech industry and academia. Our speaker will go over the lessons learned, advancements made, and the opportunities moving forward - How higher education and industry will work together in the post pandemic landscape to drive bio-innovation related to GxP and the bio-economy.

    Speaker: Jared Auclair

    Director of Northeastern’s Biopharmaceutical Analysis & Training Lab (BATL),

    Profile photo of Jared Auclair

    Collaborates with both academic researchers, industry, and government in the area of SARS-CoV-2, biopharmaceuticals and cell/gene therapy development and analysis. Academic Leader in safety and efficient drug research, regulatory approval, and patient access.

    Expertise in molecular biology, protein biochemistry, analytical chemistry, protein crystallography, and biological mass spectrometry; and is interested in use inspired research for the biotechnology industry.


    Microsoft Teams meeting

    Join on your computer or mobile app

    Click here to join the meeting

    Or call in (audio only)

    +1 646-776-1611,,922962456#   United States, New York City

    Phone Conference ID: 922 962 456#

    Find a local number | Reset PIN

    Learn More | Meeting options

    ________________________________________________________________________________



    • 23 Jun 2021
    • 11:00 AM - 12:00 PM (EDT)
    • Webinar (Start/end times are US EDT)
    • 76
    Register

    Do training metrics give you a headache?  Are you constantly telling management it’s not just about whether people are taking the training on-time or how many butts-in-seats you have?  Have you ever wondered what else we can measure that actually means something?  Well, you have come to the right place.  In this enlightening webinar you will learn the Do’s and Don’ts about key metrics that matter.  We will cover tips and tricks for tackling metrics in some of your key business functions.  We will also do a deep-dive with some case studies of conventional and some not-so-conventional metrics that you can use.   

    Who Will Benefit: - Director/Manager of Quality Training - Compliance Training Manager/Director - Compliance Policy and Training, Manager/Director - Director/Manager, QA Training - Document Control and Training Manager - VP/Director of Quality and Compliance (QA or QC), Quality Systems - VP/Director of Information Technology, Quality Management Systems, Quality Systems - VP/Director of Clinical Operations

    About the Speaker:

    John is a veteran of 30 years in the life sciences industry, first at GlaxoSmithKline, then at Merck as Executive Director, Merck Polytechnic Institute in 2008, and joining Orchestrall, Inc. as Senior VP, Talent Solutions in 2016.  His background includes Sales, Marketing, Corporate Staffs, Information Technology, Human Resources, Research and Development, and many years in Learning & Development.

    John's expertise lies in the application of learning and technology to business strategy to drive workforce effectiveness.

    He is on the Board of Directors of the Association for GxP Excellence, and was a long-term member and served on the Board of Directors of the Life Sciences Trainers and Educators Network (LTEN) for 14 years, including 2 years as president. He is also a member of the Association for Talent Development, the Society of Human Resources Management, Chair of the Board of the Asia (Global) Training Consortium, served as Advisor, National Board of Medical Examiners Clinical Research Certification, and is an advisor to the Smart Healthy City Alliance. He previously served as Senior Advisor, China Sourcing Working Committee, China Council for International Investment Promotion.


    John Constantine

    SVP Orchestrall, Inc.

    354 Lancaster Ave.

    Haverford, PA 19041-1300

    M: +1 856 316 8142

    www.orchestrallinc.com



    • 29 Jun 2021
    • 10:00 AM - 11:30 AM (EDT)
    • Webinar (Start/end times are US EDT)
    Register

    Free Informational Event - The Association for GXP Excellence (AGXPE) is pleased to announce  Navigating the Training Technology Ecosystem hosted by Kent Malmros, Sr Director, Vault Training at Veeva Systems.

    For many years, training stakeholders focused their procurement efforts on buying one key application -- and LMS. However, as the market has grown and evolved, there are many technologies available for customers to buy, implement and utilize with the goal of making the training function more strategic. But, with more options come more choices. In order to make the right choices when buying training technologies at your organization it's critical to have both a broad and deep understanding of the various solutions on the market, how they can help your training function, and how they fit together. This webinar will help attendees take a step back from the day-to-day, understand the entire training technology ecosystem and provide key tips for effectively implementing them together within your organization.  

    About the Speaker:

    Kent Malmros is Senior Director, Vault Training at Veeva Systems. Kent has spent the majority of his career delivering technology-enabled training solutions to life sciences, holding leadership positions at industry leading companies such as AdMed, ClearPoint (Red Nucleus), UL EduNeering (UL), and now at Veeva Systems. His focus has been almost exclusively on developing, delivering and supporting Learning Management System (LMS) and mobile training technologies for Life Sciences.

    All times are US EDT. 

    • 14 Nov 2021
    • 1:00 PM (EST)
    • 17 Nov 2021
    • 12:00 PM (EST)
    • The Menger Hotel, San Antonio, Texas
    Register

    AGXPE CONFERENCE

    November 14 - 17, 2021

     The Historic Menger Hotel,

    San Antonio, Texas

              

    Theme: The Compliance Frontier

    The theme revolves around one of the most historic places in America - The Alamo - San Antonio Texas. 

    The conference encompasses all activities in Innovation, Quality, Compliance, IT Quality Systems and Training.  From Clinical Trials & Studies, Good Laboratory Practices, Good Documentation Practices, GCP Deliverables,  GMP Manufacturing of Pharmaceuticals, Supplements and Biologics, Quality Testing, Packaging and After Market Monitoring, there is plenty to see and hear at this conference. 

    Once again we are assembling the best-of-the-best Subject Matter Expert Presenters & Panelists.  We promise you something for all levels of personnel from beginner to expert.

     We have already procured our first FDA Keynote Speaker: 

    Miah Jung, PharmD, MS - Pharmacologist

     Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    Registration is now open. 

    REGISTER

    Please contact agxpe15@gmail.com for details about speaking.

    Note: As the vaccine rollout continues and states and companies are returning to a sense of normalcy, this is still being slated as a live event.  AGXPE reserves the right to reschedule or convert to a hybrid/virtual event should external forces prevail!

            Conference Value Proposition  - Printable Version

    Draft Agenda- Printable Version

     

     

     

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 

Powered by Wild Apricot Membership Software