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.

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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

    • 16 Sep 2022
    • 2:00 PM - 6:45 PM
    • Red Nucleus, 19 W College Ave #300, Yardley, PA 19067 (Start/end times are US EDT)
    • 59
    Register

    The Association for GXP Excellence (AGXPE) is pleased to hold this live Mid-Atlantic Chapter meeting at the home facility of one of our sponsors, Red Nucleus (19 W College Ave #300, Yardley, PA 19067). We invite you to join us at Red Nucleus as we launch our first in-person activity since early 2020.

    The speaker information will be updated as soon as it is finalized (all times are EDT):

    • 2:00PM - Check-in open
    • 2:15PM-2:30PM - RN Opening Remarks
    • 2:30PM-2:45PM - AGXPE Leadership Update
    • 2:45PM-3:30PM - Judy Carmody - topic TBD
    • 3:30PM-4:00PM - Break / Social (Appetizers with open bar)
    • 4:00PM-4:45PM - Jack Garvey - topic TBD
    • 4:45PM-6:45PM - Food and Networking

      • 21 Sep 2022
      • 10:00 AM - 11:00 AM
      • Webinar (Start/end times are US EDT)
      • 22
      Register

      The Association for GXP Excellence (AGXPE) is pleased to announce our upcoming 60-minute webinar about dimensions of diversity hosted by Shawn M. Pelletier, Let’s Change the Equation, LLC.

      Please join us on Sep 21 for an interactive 60-minute virtual session. This webinar will broaden your views and deepen your own understanding of diversity at home and work. This isn’t the standard “Diversity” training that one might think of.  Shawn has a different way of looking at the concept of diversity and what that means.  Attendees will gain a better understanding of their own dimensions of diversity by broadening their context and application at home, in the communities where they live, and at work. This fresh look will help attendees understand that diversity is the mix, separate from inclusion and equity. 

      Space is limited, so please register as soon as you can.

      About the presenter:  

      Shawn Pelletier spent 28 years working in the pharma industry for Pfizer and Bristol-Myers Squibb.  Most of her experience was in Global Clinical Research where she gained a broad array of skills for Clinical Trials and operational process improvement.  She led numerous Clinical Business Operation departments which included leading diverse R&D teams on projects to improve efficiencies, promote teamwork, enhance inclusivity, increase quality, and decrease risk. 

      During Shawn's time in the industry, she was a member of the Association for Clinical Research Professionals (ACRP) and Drug Information Association (DIA) where she was involved in various DIA subgroups and PhRMA working groups.  She is a co-author of a chapter called Clinical Trial Registration and Reporting in the book Principles of Good Clinical Practice which is available on Amazon. Shawn was fortunate to work with all divisions at BMS (R&D, Manufacturing and Commercial) and this exposure to global, multicultural environments fueled her passion for Diversity, Equity and Inclusion (DE&I).  She had the opportunity to pivot in her career and create a new path for herself. 

      In 2020 she founded Let’s Change the Equation LLC to help companies and individuals understand and dissect DE&I challenges.  Shawn is a Certified Diversity Professional and a member of the National Diversity Council.

      letschangetheequation@gmail.com

      www.letschangetheequation.com


      • 22 Sep 2022
      • 10:00 AM - 11:00 AM
      • Webinar (Start/end times are US EDT)
      • 91
      Register


      The Association for GXP Excellence (AGXPE) is pleased to announce a new Spotlight Webinar Series hosted by Karla Robertson, CEO of Shifting Gears Executive Coaching.


      Sharpening Skills That Make a Difference

      This limited series of 4 sessions is going to zero in on specific, practical awareness and skills that all professionals need to master regardless of where you are in your career or what title you hold.  Each session will be an hour and will include content presented by Karla, some in-session practice and then Q&A. There will be two weeks between sessions. Please note that each topic does not require that you attend any of the previous sessions, although they are all connected in some way and do support each other. Please come ready to share your experiences, questions and thoughts. We all learn from each other so it’s all good!

      LOCATION:  Zoom (to be shared before 1st event)

      Session 1: Managing Your Career & Effective Networking

      Thursday, September 22 from 10am-11am EDT

      So many people do a good job at managing the work, their teams, their objectives. They also forget to manage their own career. For a long time now, it has not been enough to do your job well and trust people will notice. You will learn how to:

      • Ensure that your results, approach and presence make a difference and are noticed.
      • Tell your story.
      • Manage up.
      • Identify an advocate who has a seat at the table and how to network effectively to drive the advancement of your career.

      -------------------------------------------------------------------------------------------

      About the Presenter:

      Karla Robertson’s 20+ years in the corporate arena led her to start her own company, Shifting Gears® in 1999, specializing in mental agility coaching with leaders and executives across diverse industries. Her success as a speaker is rooted in her consistent ability to provoke a desire in her audiences to engage and develop their mental agility which ignites their willingness to make shifts in the way they think. This, in turn, helps them become more effective communicators, influencers and leaders while building their health, relationships and joy. As a coach, she has earned trusted advisor status with her clients who consistently define her candor, humor, directness and her ability to challenge their thinking and actions as the hallmarks of Karla’s value. 

      All times are US EDT.

      • 29 Sep 2022
      • 10:00 AM - 11:00 AM
      • Webinar (Start/end times are US EDT)
      • 93
      Register

      The Association for GXP Excellence (AGXPE) is pleased to announce a new Spotlight Webinar Series hosted by Karla Robertson, CEO of Shifting Gears Executive Coaching.


      Sharpening Skills That Make a Difference

      This limited series of 4 sessions is going to zero in on specific, practical awareness and skills that all professionals need to master regardless of where you are in your career or what title you hold.  Each session will be an hour and will include content presented by Karla, some in-session practice and then Q&A. There will be two weeks between sessions. Please note that each topic does not require that you attend any of the previous sessions, although they are all connected in some way and do support each other. Please come ready to share your experiences, questions and thoughts. We all learn from each other so it’s all good!

      LOCATION:  Zoom (to be shared before this event)

      Session 2: Negotiating the Ask

      Thursday, September 29 from 10am-11am EDT

      “Don’t people realize how jammed I am? Why do they keep dumping requests and demands on me?”  Because you keep saying yes! Learn how to negotiate what people ask of you, yes, even your manager or senior leader. Also, if you are a manager of others, learn how you can raise your awareness and approach to ensure your team meets their deliverables.

      -------------------------------------------------------------------------------------------

      About the Presenter:

      Karla Robertson’s 20+ years in the corporate arena led her to start her own company, Shifting Gears® in 1999, specializing in mental agility coaching with leaders and executives across diverse industries. Her success as a speaker is rooted in her consistent ability to provoke a desire in her audiences to engage and develop their mental agility which ignites their willingness to make shifts in the way they think. This, in turn, helps them become more effective communicators, influencers and leaders while building their health, relationships and joy. As a coach, she has earned trusted advisor status with her clients who consistently define her candor, humor, directness and her ability to challenge their thinking and actions as the hallmarks of Karla’s value. 

      All times are US EDT.

      • 06 Oct 2022
      • 10:00 AM - 11:00 AM
      • Webinar (Start/end times are US EDT)
      • 96
      Register


      The Association for GXP Excellence (AGXPE) is pleased to announce a new Spotlight Webinar Series hosted by Karla Robertson, CEO of Shifting Gears Executive Coaching.


      Sharpening Skills That Make a Difference

      This limited series of 4 sessions is going to zero in on specific, practical awareness and skills that all professionals need to master regardless of where you are in your career or what title you hold.  Each session will be an hour and will include content presented by Karla, some in-session practice and then Q&A. There will be two weeks between sessions. Please note that each topic does not require that you attend any of the previous sessions, although they are all connected in some way and do support each other. Please come ready to share your experiences, questions and thoughts. We all learn from each other so it’s all good!

      LOCATION:  Zoom (to be shared before this event)

      Session 3: Feed-Forward (not Back): Having More Effective and Less Stressful Performance Conversations

      Thursday, October 6 from 10am-11am EDT

      Isn’t it time we relook at how we communicate in real time how our team is doing as well as get that same information coming back to us? There is a better way to do this that is based on the work of Dr. David Rock, founder of the Neuroleadership Institute. Participants will learn a practical, simplified way of giving and receiving useful performance assessment in a mutually beneficial conversation.

      -------------------------------------------------------------------------------------------

      About the Presenter:

      Karla Robertson’s 20+ years in the corporate arena led her to start her own company, Shifting Gears® in 1999, specializing in mental agility coaching with leaders and executives across diverse industries. Her success as a speaker is rooted in her consistent ability to provoke a desire in her audiences to engage and develop their mental agility which ignites their willingness to make shifts in the way they think. This, in turn, helps them become more effective communicators, influencers and leaders while building their health, relationships and joy. As a coach, she has earned trusted advisor status with her clients who consistently define her candor, humor, directness and her ability to challenge their thinking and actions as the hallmarks of Karla’s value. 

      All times are US EDT.

      • 13 Oct 2022
      • 10:00 AM - 11:30 AM
      • Webinar (Start/end times are US EDT)
      • 94
      Register


      The Association for GXP Excellence (AGXPE) is pleased to announce a new Spotlight Webinar Series hosted by Karla Robertson, CEO of Shifting Gears Executive Coaching.


      Sharpening Skills That Make a Difference

      This limited series of 4 sessions is going to zero in on specific, practical awareness and skills that all professionals need to master regardless of where you are in your career or what title you hold.  Each session will be an hour and will include content presented by Karla, some in-session practice and then Q&A. There will be two weeks between sessions. Please note that each topic does not require that you attend any of the previous sessions, although they are all connected in some way and do support each other. Please come ready to share your experiences, questions and thoughts. We all learn from each other so it’s all good!

      LOCATION:  Zoom (to be shared before this event)

      Session 4: Say It In Six: Distill Your Message To Its Core.  (Based on the book by Ron Hoff)

      Thursday, October 13 from 10am-11:30am EDT

      This session will give volunteers from the participants a chance to “say it in six” and receive real time observations from the group. This practice is about distilling your message to its core so as not to exhaust what little RAM humans have in the working memory of their brain. You will learn to hold more effective, short and productive meetings that engage your audience and team…they will thank you for it.  You will also gain quicker buy-in because you are not burying people in extraneous information they don’t need or want and which gets in the way of your key point and making an impact.

      NOTE: This session requires attendees to purchase of the book Say It in Six by Ron Hoff and reading through it in advance as well as creating an SIIS presentation. A few volunteers will be selected to give their 6-min. presentation in-session and receive observations from the group. Karla will communicate to all attendees to ask for volunteers willing to make their SIIS presentation to the group. First come, first selected!

      -------------------------------------------------------------------------------------------

      About the Presenter:

      Karla Robertson’s 20+ years in the corporate arena led her to start her own company, Shifting Gears® in 1999, specializing in mental agility coaching with leaders and executives across diverse industries. Her success as a speaker is rooted in her consistent ability to provoke a desire in her audiences to engage and develop their mental agility which ignites their willingness to make shifts in the way they think. This, in turn, helps them become more effective communicators, influencers and leaders while building their health, relationships and joy. As a coach, she has earned trusted advisor status with her clients who consistently define her candor, humor, directness and her ability to challenge their thinking and actions as the hallmarks of Karla’s value. 

      All times are US EDT.

      • 26 Oct 2022
      • 10:00 AM - 11:00 AM
      • Webinar (Start/end times are US EDT)
      • 26
      Register

      The Association for GXP Excellence (AGXPE) is pleased to announce our upcoming 60-minute webinar about psychological safety hosted by Shawn M. Pelletier, Let’s Change the Equation, LLC.

      Please join us on October 26 for an interactive 60-minute virtual session. This webinar will deepen your understanding of Psychological Safety and how it impacts your actions, regardless of your role as an individual contributor or a manager of projects or people.  

      We will dive deeper into understanding Psychological Safety, as well as one’s own actions that may be promoting or impeding efforts to build a psychologically safe environment.  A psychologically safe environment is the belief that you can speak up with ideas, questions, or concerns and you won't be punished, humiliated, or marginalized in some way for doing so.  The feeling of being safe at work is more than just words spoken at a meeting or flashed up on a screen in a power point presentation.  The feeling of psychological safety is based on the actions and reactions that you directly experience.  What is “safe” to do or not to do within a workplace, is based on an employee’s lived experience. 

      Space is limited, so please register as soon as you can.

      About the presenter:  

      Shawn Pelletier spent 28 years working in the pharma industry for Pfizer and Bristol-Myers Squibb.  Most of her experience was in Global Clinical Research where she gained a broad array of skills for Clinical Trials and operational process improvement.  She led numerous Clinical Business Operation departments which included leading diverse R&D teams on projects to improve efficiencies, promote teamwork, enhance inclusivity, increase quality, and decrease risk. 

      During Shawn's time in the industry, she was a member of the Association for Clinical Research Professionals (ACRP) and Drug Information Association (DIA) where she was involved in various DIA subgroups and PhRMA working groups.  She is a co-author of a chapter called Clinical Trial Registration and Reporting in the book Principles of Good Clinical Practice which is available on Amazon. Shawn was fortunate to work with all divisions at BMS (R&D, Manufacturing and Commercial) and this exposure to global, multicultural environments fueled her passion for Diversity, Equity and Inclusion (DE&I).  She had the opportunity to pivot in her career and create a new path for herself. 

      In 2020 she founded Let’s Change the Equation LLC to help companies and individuals understand and dissect DE&I challenges.  Shawn is a Certified Diversity Professional and a member of the National Diversity Council.

      letschangetheequation@gmail.com

      www.letschangetheequation.com


    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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