RESOURCE SPOTLIGHT
John Constantine and John Lewis
The Association for GXP Excellence (AGXPE) and the Life Sciences Trainers & Educators Network (LTEN) have launched a new collaboration to broaden access to high.value, member-driven learning.
LTEN has historically been the go-to association for life sciences learning and development (L&D) professionals, with the membership historically dominated by commercial colleagues. It has been an LTEN goal for quite some time to expand offerings to those L&D colleagues in research and development (R&D), manufacturing, quality and other regulated functions at member companies.
In a way, AGXPE has been the obverse; membership that comes from many of the same companies and dominated by the same regulated areas with little representation from the commercial function.
With membership of both groups having similar interests (L&D) and very complimentary audiences, it seemed like an easy decision for the two groups to collaborate. The two professional networks decided to undertake their first collaborative effort at the LTEN2026 annual conference, June 15-18 in Kissimmee, Fla.
While LTEN members are quite familiar with commercial, HR and skill-building L&D topics, they may be less familiar with GXP training topics, and the special challenges faced in the regulated areas.
GXP stands for “Good ‘X’ Practices,” a set of multidisciplinary standards that must be strictly adhered to in addition to regulations from agencies governing the research, development and production of pharmaceutical products. The “X” is a variable placeholder; for example, there are good clinical practices, good manufacturing practices, good laboratory practices, good pharmacovigilance practices and others. People who work in these areas must perform their jobs according to regulations and these GXPs.
In the manufacturing area, FDA regulation 21 CFR Part 211.25(a) states that, “Each person engaged in the manufacture, processing, packing or holding of a drug product shall have education, training and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with current good manufacturing practices (CGMP) requirements applicable to them.”
Put simply, L&D in these areas is specific, regulated and must be tracked to be able to show to an FDA inspector on request.
There are some challenges in GXP training. The regulated nature of the training tends to make companies overly cautious and process oriented. This has resulted in 75% of all GXP training (high volume to begin with) being assigned standard operating procedures and/or work instruction documents.
We all know this is not an effective training modality and this is beginning to change rapidly across the industry. We’ll be discussing these changes in our LTEN2026 workshops.
This is where the value of this new collaboration will be felt – commercial trainers get to network with a new audience of colleagues and the GXP trainers will be able to take advantage of the power of LTEN membership.
Here’s a sneak peek at some topics we’ll cover at the conference:
Proposed FDA Guidance on GXP Training
People Centricity in the Age of AI
Designing Unforgettable Training: Matching Knowledge Types with Strategies for Better Learning Experiences
Effective GXP Communication
Root Cause Analysis That Works: Moving Beyond “Human Error”
GXP Training Reimagined: Modernizing Mindsets, Methods and Mastery
And, our “super session” on the final morning, GXP Training: We’re Doing It All Wrong.
The partnership provides AGXPE members streamlined access to LTEN programming, including a dedicated conference registration pathway, complimentary LTEN membership with registration and an AGXPE-curated GXP track at the LTEN annual conference. Together, AGXPE and LTEN are strengthening professional development, expanding networking opportunities and elevating the voice of the GXP community across life sciences training.
John Constantine is the senior vice president, U.S. consulting, at Orchestrall, a former LTEN Board of Directors president and an inductee in the LTEN Hall of Fame. Email John at john.constantine@orchestrallinc.com or connect through linkedin.com/in/john-constantine-38458a.
John Lewis is the director of operational excellence for R&D at Merck & Co. and one of the original founders of AGXPE. Email John at john_m_lewis@merck.com or connect through linkedin.com/in/jmlew.