One of the most interesting experiences of my career at Allen has been the chance I had a few years ago to tour a pharmaceutical manufacturing facility. I got to see firsthand how pharmaceuticals are manufactured in bulk and what sorts of quality issues typically need to be addressed. We dressed in sterile white protective clothing and saw vats of e-coli bacteria being used to harvest particular DNA sequences. It was like being in a science fiction movie—it was definitely not the type of corporate environment often targeted in healthcare compliance training.
Since that experience several years ago, we’ve had the chance to do several projects for clients in the pharmaceutical industry and we’ve noted that the design and development of training for this particular industry really does have some unique challenges. Let’s start with design. All learner populations are unique, of course, but we’ve found that pharma learners tend to be more idiosyncratic as a learner audience. A generic audience profile just doesn’t fit. One of our clients, for example, had a large number of MDs and PhDs on their team. These learners didn’t like web-based training because they didn’t like “silly activities”—they wanted to be able to get in and get out, with ready access to just the information that they needed. When we started working with this audience, we had to win them over by creating highly relevant, work-based learning activities that gave them the access and flexibility that they needed. It also needed to double as a knowledge base. We designed a course organized around the roles of those taking the training—where they could select the scenarios most applicable to their jobs and would have the option of reviewing an abstract before committing to the scenario.
We’ve also learned that this audience is drowning in documents and policies. Dealing with this type of regulatory content means that you really need to emphasize people and the ways that these documents are actually used. Another thing we try to do is to create a connection to the real-life consequences that such documents have for patients. Once, when I was working on a course on quality assurance, the conversation with our subject-matter experts quickly turned to the importance of what they do—how they personally depend on the quality of their own company’s drug products and how they have a hyperawareness of things like lots numbers for particular batches of a drug, etc. By having these types of conversations, we can create a better context for the training, one that includes the human why behind the black-and-white standard operating procedures.
Of course, when there are real consequences, there are also legal implications. We have had to develop best practices for working with our clients’ legal departments. I remember a course on ethics where everything—including the dialogue for characters in a media segment—had to go through an elaborate process of negotiation and approval. In response to this need, we developed processes for working with the subject matter experts that would provide us with a legal opinion of the content much earlier in the process, before moving into more costly design and development. We began including a member of the legal team as part of the project team, involving him or her in the kickoff and content analysis activities. Very quickly, we had a toolkit that helped our client determine who should be involved in which steps of the process, which criteria should be used to select the appropriate team members, etc. We also had worksheets to gather the right scenario components and checklists to ensure that we followed the most efficient process throughout the development cycle. Taking this type of approach enabled us to gear up and anticipate the types of legal issues common in the development of this particular type of custom training.
Tags: compliance training, healthcare training, Pharma Training,