For Life Science Companies

Nancie E. Celini

Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program - Part 2
by Nancie E. Celini, GxP, Learning Program Lead

Oct 06, 2010 | Free Downloads | email | Print

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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.

Employees need to fully understand their job roles and responsibilities in context as regards the regulations that keep the organization compliant.

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 roles and responsibilities in context; they also need to understand the regulations that keep the organization compliant.

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—interpretations. 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 online 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.

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 can help 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 online 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 the patent expirations and tough business and scientific challenges we all face, it is often difficult to justify the type of program that I have described. But I can vouch that training needs to change in the life science industries 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."

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 transformations from training to learning in the changing life science industries, please feel free to reach me through Carl's blog. I want to say a great big thank you to Carl for providing his blogspace for thoughtful discussion and insight. I hope you have enjoyed these thoughts on GxP education.

Good luck and good learning!

Reprinted from GxP Perspectives with permission

Nancie Celini is president and founder of CAB, inc., a technology and training-consulting firm specializing in life science systems and learning programs. Ms. Celini is an experienced system professional and educator with over 30 years of project work spanning document, records and clinical data management systems used during product development. CAB, inc. develops unique organizational learning strategies for renewing and improving information system projects and GxP learning programs. She has developed a diverse number of programs for numerous life science organizations as well as academic and government environments. She began her career with Xerox in 1976 where she helped introduce professional workstations and publishing technology to the pharmaceutical industry. She formed CAB, inc. in 1986, a female, wholly-owned NY corporation and has been actively engaged in independent project work since that time.

Ms. Celini has a diverse education in healthcare information systems and public health and received her MPH from New York Medical College in Valhalla, New York where she currently teaches Healthcare Economics and is earning a doctorate in public health policy. Her work was featured in 2010 on the New York Times Knowledge Network in collaboration with academic colleagues in an on-line course about healthcare economics and reform. She is an experienced classroom and e-learning developer/instructor and is an active member of the Drug Information Association and original U.S. Chair of the Document and Records Management SIAC. She led this volunteer effort in the development of a common reference (taxonomy) model that continues to evolve in hopes to ease the economic and technical burdens on pharmaceutical companies when implementing information repositories systems.

Ms. Celini is an experienced meeting facilitator, instructional designer, international trainer and voice-over professional. She can be reached at: for comment and further discussion regarding the intersections of public health, pharmaceutical and regulatory science, policy, technology and learning.

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