Managing Training in a Regulatory Environment

I ran the Learning Management System for a major Pharmaceutical company. I had to learn quickly what it meant to track regulatory compliance training. The FDA wants to know that if someone’s work affects the safety of workers or patients, that that person was properly trained to do their job. If you use an electronic system to prove that fact, that system better be run in a very disciplined way in order to assure that the data that went in is the same as the data that comes out. This is called validation. What it means is that you designed a system that meets the needs of the business and you build a system that can be shown to meet those needs. The problem with a Learning Management System is that training groups want the advantages of using a single system but they want the autonomy of having their own system. Validation implies a single process.  What is really needed is an unbroken chain of accountability. It works like this:

  • The course owner is tasked with training a population on a subject. The course owner is responsible for the content and for seeing that it is implemented and that there is full compliance. The course owner decides the criteria for completion of the course.
  • The course owner delegates responsibility to the designer to create the course but the course owner signs off.
  • If it is an instructor led class, the course owner delegates the instructor to take responsibility for their students completions. When the instructor signs the roster, they are certifying that the students have met the criteria of completion.
  • When the instructor submits the roster for data entry, the work is performed by someone who is authorized to use the system. That entry becomes a regulatory record.
  • For eLearning, the designer must include a validated process for transferring successful completion records to the Learning Management System.
  • Any process or exception that breaks those chains of accountability, puts the authenticity of the data into question and can lead to a finding during an audit.

It is the Policies and Procedures document that defines the parameters of this accountability and let’s the training groups know where they have the leeway to use their autonomy without jeopardizing the integrity of the system. When this is clear, it is possible for independent training groups to work in a global system.

The question is, how will the changes to learning (social media etc.) affect this process? How do you maintain the accountability for informal learning. I look forward to exploring this in future posts. Let me know your thoughts.



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