Podcast 7: Assuring Excellence! Inside the Role of QA Director in Contract Research Organization

So I think any CRO kind of dealing with data, especially electronic data, needs to make sure that data being generated cannot be hacked, cannot be corrupted, cannot be deleted, cannot be modified by any malicious means or any means really, even accidentally.

Hello, everyone. Thanks for joining us today. My name is Niku. I'm the Director of Operations and Corporate Development at Emory Pharma. Today I'm joined here with Hubert Lin, who's our Director of Quality Assurance at Emory Pharma. So to start off, Hubert, maybe you could tell us a little bit more about your background and your role at Emory Pharma.

Hello and thank you for having me, Niku. Again, like NICU mentioned, I am Huberlin. I am the Director of Quality Assurance here at Emory Pharma. A little bit about myself. So I got my bachelor's at UC Davis in biomedical engineering, and I then got my master's in biotechnology at the University of San Francisco from there. I actually started in the industry at about 10 years ago, right around right after I graduated with Ron, actually, our lovely CEO of Emery Pharma. I worked with him about 10 years ago. Kind of had my start there at Nova Day, and then in 2016, I then moved over to Emory Pharma, and then kind of continued the quality assurance work from there.

Okay, great. Thank you for that background. Do you mind kind of telling us a little bit more about, you know, quality assurance's role within a CRO?

So, really, the primary role quality assurance plays is to ensure the reliability and accuracy of the data generated at a CRO. So really, a lot of my experience and kind of my responsibilities centers around making sure that happens, which includes kind of maintaining the quality management system surrounding all of that and then also overseeing any regulated projects involved in generating that sort of data.

Okay, and what would you say are some of the kind of key elements that are important and very crucial for maintaining quality within a CRO?

So a few things come to mind. I would say meticulous documentation, as everyone likes to kind of poke fun at qa, is a lot of paperwork, but having all that documentation really helps kind of keep track of all of the data and making sure everything is reliable that we generate. Obviously, adhering to any of the protocols that we have is very important. If you don't have these standard protocols and we don't adhere to them, you know, that we're not following regulations, and then, of course, having to check all of that through regular internal audits, I would say another key component would also be clear and constant communication with our clients, because obviously, we have our own regulations. We follow. We do follow FDA Torrent CFR part 58 and 21021 1, which is GLP and CGMP, respectively. But sometimes the client might have some other regulations as well, and we need to be clear with the communication with them to make sure we know what to follow there, and then to make sure we are compliant with what they want us to be compliant with.

And then how would you say that, you know, a lot of the CROs are staying compliant with regulatory standards.

There are a few ways to kind of do that. One of the easier ways is a lot of these kind of compendial websites have notifications you can subscribe to. Like, for example, if there's like a chapter that gets updated, you can get an email notification. And then from there you can be like, oh, this updated. Let's see if we need to update anything internally within our procedures. Working with other QA professionals as well helps a lot because different QA from different companies might have different perspectives on certain regulations. It's always really nice to kind of hear what they have to say, especially if you have, like, a problem you're not sure how to deal with. It's sometimes nice to reach out and see what other viewpoints they have. And then again, like I mentioned, kind of collaborative collaborating with clients is the best way to do this because again, their regulations on what they need can kind of help us adapt and kind of shape how we kind of follow these regulations as well.

Okay, and then, you know, how would you suggest that, you know, within maybe Emory Pharma or within other CROs, how are personnel really adequately trained to make sure that they are compliant within the organization? Are there any necessary skills that they may need potentially, you know, along with that? What kind of certification or training would someone in quality assurance need to be compliant or kept up to date with the regulatory standards?

So training usually is determined beforehand, depending on their job description, kind of what we sign them up to do. Obviously, that being said, training is also kind of dependent on kind of continuous improvement from there. Continuous improvement kind of stems from having feedback either internally or from other clients, depending on the outcome of the project. I would say a good portion of that continuous improvement would be feedback from clients, just because depending on what we do for them, right. We can always learn something from working with our clients. Another, I guess, another in that being said, another key component in training would be kind of what I consider critical training, which is basically a set, a subset of the procedures that we follow in a company where we deem Critical, which means, like, these topics need to be regularly reviewed. For instance, data integrity, good documentation practices, any instrument test methods that the people need to know. We want those to be constantly reviewed to ensure that the personnel are kind of up to date with that. And I guess in terms of certifications for qa, which I'm assuming is what you're asking, like, if you kind of want to do any like, specific QA training, there are programs out there. I know some colleges offer courses, like actually full, like programs basically that you can get a QA certificate in. There's also professional development societies which you can attend and become a member of. I know these societies offer conferences. You can attend, for instance, also other seminars, some workshops. The American Society for Quality ASQ is one of these societies that come to mind. I know there are a bunch of others as well, but those are kind of a couple ways I could think of to kind of enhance your quality insurance expertise.

Okay, great. And kind of just to maybe go back to some of the challenges that, you know, CROs face to stay compliant with all of these ever changing, you know, processes and requirements. What would you say are kind of some of those challenges and then how would the CROs address these challenges?

Sure. So I think one of the biggest challenges, at least in my experience, would be kind of compliance with your own procedures. So we write all these procedures, but then sometimes we don't follow them all. So usually I would say, like, the best way to do this to kind of address that issue would be prevention. The best way of prevention would be training. Right. We want to train the personnel to make sure they are following the procedures as written. On top of that, any internal odds to kind of catch any non compliances also helps a lot too. So that's one of the big ones. Another big one I can think of would be data integrity. So I think any CRO kind of dealing with data, especially electronic data, needs to make sure that data being generated cannot be hacked, cannot be corrupted, cannot be deleted, cannot be modified by any malicious means or any means really, even accidentally. Again, as mentioned before, I think training and internal audits kind of help prevent that from happening again. Training to make sure the personnel know what to do with the data, not to overwrite any data that they generate, not to delete data, accidentally know what to save the data, stuff like that. And of course, the training kind of prevents, hopefully prevents any potentially disgruntled employees from access to stuff they shouldn't have. And again, Audis is there to make sure the data that's being Generated has been validated and verified and it is actually the correct data. And of course, I think also on top of all that, a lot of CROs also invest in a lot of kind of robust data management systems. So, like, what do they call it? Like caches? Inaccessible caches where only data admins can access. So that kind of limits access as well. But yeah.

Okay, great. So what kind of advice do you have for someone who's looking to get into quality assurance? Learn a little bit more about what kind of regulatory standards are out there as it relates to a CRO?

For someone getting into qa, I'd say the best or not the best. The usual advice kind of applies here. If there's any certification you want to get, feel free to get those. If there's any kind of training seminars, programs to attend, attend those. I think obviously working with other QA professionals help a lot, staying updated on industry trends. I mean, I know there are also some journals out there that occasionally print out any upcoming trends in the QA sort of thing. I think, however, the most important thing in getting into QA is kind of knowing what you're signing up for. Because I feel like QA requires a certain kind of mindset to kind of approach this sort of work. This sort of work. As, you know, as I've, you know, we've talked about this whole time, you know, there's a lot of rules kind of governing everything we do in qa. Regulations, you know, laws, standards. But QA really isn't just about understanding what those rules are. It really is kind of knowing the rules and then how to apply them. That means depending on the kind of work we have to do, maybe this regulation applies, maybe it does not. You have to be kind of flexible. And that does require, of course, understanding the regulations, but then also kind of requires some, a certain degree of flexibility and kind of understanding of what you are applying. I think that is really important and I think it is also really important that you're able to kind of adapt to these sort of things as well. Right. You can't just be a stickler to the rules and can't be inflexible to that at all. Because I think especially in our line of work, CRO's, we have a lot of clients that have a lot of different needs, and depending on what they want, we might have to adapt our procedures. We may have to kind of update our procedures depending on what they need. So I think that is really important. I think that's probably the most important aspect of all in qa.

Okay. Well, thank you so much. As you know, Emory Pharma is very committed to staying up to date with all of the new regulations and adapting to all the changes within the landscape as it relates to quality assurance and regulatory support. So we really appreciate your time today, Hubert, and sharing more about quality assurance and, you know, the importance of it within a CRO. Thank you for your time today.

Of course. Thank you. It was my pleasure.