GxP Training Part 2: Regulatory Compliance for FDA Regulated Industry


GxP compliance FDA training

What is the Best Method of SOP Training for GxPs?

GLP; GCP; GMP; GxP, just how may good practices do you need to know in the world of regulatory compliance for FDA regulated industry? In part 2 of this Guest Commentary by training specialist Nancie Celini she discusses the pitfalls of “Read and Understood” as a concept for GxP training on standard operating procedures. This was discussed last week at a training workshop at the Drug Infomation Association’s (DIA) Annual Meeting. While I prepare some comments on my favorite sessions I am giving you part 2 of Nancie’s excellent commentary.

Guest Commentary
Part 2:
Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program
June 9, 2010
Nancie E. Celini, GxP Learning Program Lead

In the previous article I discussed the use of the acronym “GxP” as well as regulations, a changing industry landscape and some suggestions for becoming a learning organization. In this article we will look at learning and why having a strategy, leadership and a comprehensive program is so important in our work and to our future success.

Sponsor organizations have traditionally relied upon a “Read and Understood” approach for instructing its workforce on procedural documents (e.g. Policies, SOPs, working instructions). While this may be a reasonable approach for certain procedures, this method can be unreliable. Reading procedures alone, without additional context and details may leave an organization vulnerable. Employees need to fully understand their job role and responsibilities in context as regards the regulations that keep the organization compliant.

regulatory compliance FDA

FDA Requirements for Training and Experience


FDA has (and will) cite companies for deficiencies in their training programs. U.S. regulations can be broad and subject to loose and often incorrect interpretation. The regulations stipulate that personnel must have “training and education and/or experience” to enable them to fulfill their role. In today’s dynamic e-clinical environment where many functions are virtual and rely upon third parties, this phrase takes on new meaning.

GxP learning programs must be robust and comprehensive and should include the following components:
• Introductory Level (GCPs, GMPs and/or GLPs) for new employees

• Policy and provision for outsourced / consulting personnel who perform regulated activities for you

• Yearly refresher GxP courses that don’t just recite regulations but focus on changes to existing regulations as well as emerging guidance and trends of health authorities / regulators (as well as the political context / global issues / economics and externalities)

• A blend of leader-led and on-line courses (e.g. a “hybrid” model)

• Qualified learning professionals / instructors who lead, manage, deliver and sustain the program

Complete training records; current organization charts; descriptions of roles and responsible parties in the chain of authority; current job descriptions and records of training courses completed linked to roles / responsibilities

• Curriculum Vitae (updated as changes occur)

• Organizational Training Policy and SOP that govern the overall GxP program

A GxP learning program should be role-specific regarding organizational job descriptions and collaboration across functions (clinical, regulatory, human resources, training, etc.). This is critical and likely to be where gaps in procedures and training can occur. Personnel need to understand how procedures relate to each other. Often there is no reference from one process to another that creates these gaps that can lead to deficiencies and ultimately, citations.

FDA training GxP

Are There Advantages to a Learning Management System?

Many organizations have invested in a GxP learning program that includes some of these elements but leadership and strategic planning combined with a learning management platform (a.k.a. LMS) can help to streamline content delivery as well as training records management. Efficient programs can be ramped-up very rapidly and when the paper is removed and an LMS is integrated with an electronic document management repository that manages the lifecycle of procedural documents. An LMS can help an organization save time, money and create an exciting and engaging program when combined with a rich assortment of industry courses. Content that is updated annually and delivered through a low-cost hosted, 21 CFR Part 11 validated system is a goal worth striving for. An LMS is no longer a solution for a large organization. The LMS market has stabilized more than in previous years and there are economical solutions for small organizations as well as robust systems that can support large global organizations.

But don’t forget the classroom. Leader-led sessions enhance the read and understood approach especially for procedures and allow professionals to work collaboratively. And the right LMS can manage your leader-led program as well as your on-line content.

As an educator I want to close by giving you some retrospective history about “training” in our industry. At one time training departments were plentiful in this industry with knowledgeable trainers who were committed to their trade. Due to previous economic downturns, the industry started to downsize and cut many training programs. Sadly, it has been hard to come back from these difficult times and we find ourselves in the midst of climbing out of yet another tough economic trough. Considering patent expirations and tough business and scientific challenges we all face, it is often difficult to justify a program that I have described. But the business of training needs to change in our industry as I’ve seen too many deficient programs that have been relegated to an unimportant level in many organizations. Here is something to reflect on from John Dewey;

“Any genuine teaching will result, if successful, in someone’s knowing how to bring about a better condition of things than existed earlier.”

GxP training FDA compliance

GxP Training for Regulatory Compliance

Isn’t it time for our industry to learn collectively how to bring about a better condition? As an industry we all need to remember that our work is focused on how to ease human suffering and the search for new remedies to cure disease and improve human health. How will we all learn to do better without the right tools and insights? This is the challenge we all face as we rebuild and renew our organizations during this time of unprecedented change.

If you are interested in this topic or further discussion about transforming from training to learning in this changing industry, please feel free to reach me through Carl’s blog. I want to say a great big thank you to Carl for providing this space for thoughtful discussion and insight. I hope you have enjoyed these thoughts on GxP education.

Good luck and good learning!

Read Part One of Nancie’s training article

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

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GxP Perspectives LinkedIn Group

2 Responses to GxP Training Part 2: Regulatory Compliance for FDA Regulated Industry

  1. Hi Nancie:

    Thanks for the post and for underscoring the importance of how creating the learning culture can transform our industry.

    As a fellow clinical research learning and development professional I focus my efforts on setting clinical research teams up for flawless study execution and ultimately audit success. Learning as you described is key to the health of our industry.

    In addition to the modalities you described I would also add social or informal learning to the mix. This could take the form of teaching others on your team about a study procedure or good clinical practice, participating on an SOP committee, engaging in a mentoring program, or participating in a lunchtime discussion group.

    I recommend these less formal learning opportunities get documented on a training log; they are easy to forget to include as learning activities but can be very powerful tools augmenting instructor led or e-learning.

    Thanks for the opportunity to comment.

    Kind Regards,

    Natalie Currie
    Natalie Currie, Clinical Research Consulting Inc.

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