Session 1: Building Your Quality/GxP Training Program

Session 1 of 5 explains how to organize your controlled documents and align them with role-based qualifications for a functional training matrix.

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Hey, everyone. Ken Malmros here, Senior Director of Vault Training at Veeva Systems. I’m joined by my good friend, John Constantine, SVP at Orchestrall. We’ve been and do a series of fireside chats about key topics in life sciences training. And in our current climate, we decided what the heck, we’re just going to do it anyway. We’ll just make them zoom side chats, if you could call it something like that with our virtual backgrounds here. Still, the topics are relevant, maybe even more relevant today than they’ve ever been. So happy that John can join me.

John, why don’t you introduce yourself and tell everyone a little bit about your background.

Thanks, Ken. And thanks to Veeva for hosting this. Yeah, I’ve spent a lot of years in the life science industry. I spent two decades at GlaxoSmithKline, another decade at Merck. Most of those years spent in learning and development, both on the commercial side, R&D side, enterprise, IT, HR. And now for the last four years, I’ve been running a consulting practice at Orchestrall, helping companies take training to the next level.

So basically you’ve done everything in the training space and life sciences, which makes you a perfect person to talk about all these topics. So let’s start with our first, which is building your quality or GXP training program. And John, we know this is a topic that many people deal with as their companies are emerging and really it can create a lot of confusion. So let’s start with how to think about key milestones or triggers for an organization. When should they really, as an emerging life sciences company, be thinking that it’s time to develop that comprehensive program for GX peer quality?

Yeah. So I’ve done a lot of work with emerging companies from pure startups with five, six employees, all the way to that 100, 200, 300 person company, and really the earlier the better is the best answer. When you’ve just started up and you have five people, you may not be thinking about interacting with agencies yet and all the records and the rigor that goes along with compliance and with regulations and the training that is associated with that. But you really should be thinking about it as early as possible and formulate a strategy that will grow with your company.

Yeah. It’s interesting. I know some of my colleagues, when we talk about this, think the right company to target for discussions around training is maybe between phase two and phase three clinical trials and the first product, but I’m with you. I think that’s actually maybe a little too late because it simpler to develop the program when you’re smaller and grow with it instead of trying to fit a larger organization to a program, and that can be very overwhelming. So with that in mind, where do you think organizations should start? Maybe think about it from the perspective of ownership and responsibility, who should take this project on?

Well, ownership is a little bit of a tricky subject because just by nature of the way companies work and organizations work and compliance works, you have you in any organization, multiple owners of being compliant. So you have quality, you have research, you have development, HR. Even in the commercial space, you have compliance that needs to be adhered to. And so ownership is difficult. I’d like to think more in terms of governance than ownership because you’re are never going to get one place where all of the compliance training needs are owned.

But if you have good governance structure where everybody’s talking to each other, then you have the ability to have a coherent strategy and you don’t have to call me in later on to do recognition.

Yeah. Fair enough. And so governance in terms of responsibility and own start with maybe the point of need. And so let’s talk a little bit about what that means. Because typically I think you and I have talked in the past about how you are beginning these programs when you’re maybe expecting a visit from an inspector or someone from a regulatory agency, and what they want to see is that you have created a series demonstrable qualifications for people to do their job. So maybe talk a little bit about where you start with that process.

Yeah. If you sort of waited till you’re expecting a visit from an agency, you’re probably a little too late. You need to have thought about it beforehand and taken particularly the regulated roles that cover the most people, maybe the 80/20 rule where you look at the 20% of roles that cover 80% of the compliance and regulatory issues, and make sure you’ve thought about and documented the qualification process, the training process, the training records process.

If you’re not perfect, and nobody is perfect, the agency is going to put a lot of stock in you showing good faith and having thought about it and putting a good plan in place.

Great. Yeah. I think that’s excellent advice. I know we could talk about this for a lot longer, but we have other critical topics to move on to, including things like creating a learning strategy, how to apply modern learning frameworks. I so forward to that conversation as well. Excellent advice, John. One last thought before we close on this topic.

Yeah. You’d just alluded to it about the strategic discussion. I think in the next few topics, we’ll talk about creating a plan that will be that show of good faith to the agency when they come in.

Great. The thanks, John. Please join us for the next topic. We really enjoyed this.

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