Women Leading Validation Spotlight: Wendy Haines - Continuous Learning and Professional Societies

For today’s Women Leading Validation spotlight conversation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Wendy Haines, PhD, DABT, ASQ CQA, Director of Toxicology & Technical Services at PharmEng Technology

Wendy has impacted human health laws at Environmental Protection Agency (EPA) starting in 1997, worked on the Genome Project between EPA and National Institute of Health (NIH), and later conducted her PhD at EPA. Wendy was a study director and functioned as single point of contact for all aspects of a study for both commercial clients and the government. She then moved from a contract laboratory setting to a consultant company providing toxicology, project management, and validation services to pharmaceutical and biotechnology manufacturers. Dr. Haines has conducted over 350 product toxicology safety risk assessments for contract manufacturers and owner companies and provides guidance on product testing, worker safety programs, cleaning validation, and extractable and leachable projects.

Wendy’s unique perspective, understanding of professional societies – how you can participate, volunteer and network with others to expand your knowledge.  

*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a joint Podcast production of ProcellaRX and KENX

Transcript

Dori Gonzalez-Acevedo: 0:00

Welcome to another episode of women technology. Wendy has impacted human health laws at the EPA, starting in Wendy was a study director and function as a single point of She then moved into contract laboratory settings to a Dr. Hayes has conducted over 350 product toxicology safety risk Wendy's unique perspectives of understanding professional Well welcome Wendy to women leading validation.

Wendy Haines: 1:34

Thank you for having me. I'm excited to have

Dori Gonzalez-Acevedo: 2:00

Can we start off with you giving us a

Wendy Haines: 2:10

Okay, so to start back, the reason why I wanted to the 70s, and 80s. I just thought that was super cool that he schools with pharmacy, and then the school that I went to at partnership with the drug industry, one of the first of And it really introduced me to wow, look at validation, and but okay, we have some guidance here. You're not just making it School of Pharmacy, and they hired me the day after I then I did my doctorate at a federal agency at the make sure everything I do applies to the industry. So I I wanted to make sure it was applicable to the drug industry, physiology, because when I interviewed study directors that Did you wish you knew and they said, I wish I knew anatomy stuff worked with the National Toxicology Program, part of it, It was a mathematician. I didn't like I didn't love math that SOPs, I was writing methods and doing various things at the we couldn't pay you, you have a PhD. And I'm like, It's not That experience was amazing how many people can say they helped and make it better by getting drugs to the market. Whatever cross contaminating and preventing recalls. So I have over the place. I'd never done it before. But they knew the way foray. And then I worked on more of okay, here's a training second, you have a PhD? Like they were very confused people.

Dori Gonzalez-Acevedo: 8:12

So one of the things I like about what And I think that part of that mindset, right, is if you've

Wendy Haines: 8:47

Right, so I'll give an example of because they to push out to their whole global network. We were one of a consultant could actually do change controls that were It was amazing. We had such great teamwork, but the reason As a college like she's a toxicologist. Well, yes, I'm a of 100 plus people, and know where they're at and their diversity, the right background. So when issues did arise, we had should get quality involved at the beginning, you should get So that's why I'm passionate about it. Because my PhD advisor into a lot of different projects, globally, for what the goal was that I had to summarize things, I had to see did well. And knowing that, you know, she's got 30 years of I never even thought about thinking about this paper, who are 20 to 23, that have just graduated because they're gonna with people some of the best people in validation are English quickly, right? They can write something.

Dori Gonzalez-Acevedo: 13:09

Yeah. So one of the couple things in what My graduate advisor was also a woman. And for me, those have in my career, is that something that's same for you? Or can you

Wendy Haines: 13:42

Whenever I think about situations, or you might from being the head first female head of the National Toxicology she was also the head of the National Toxicology Program. And goals, aspirations, but hands down, they greatly and I told was really interesting because they were all the same age. They back to me. And also I was gonna say another thing that not home? Do you want to work part time, like, whatever you want to though I did choose pharmacy, undergrad, but then I went on mom went back to math and said, math doesn't change. So that was family support to not just bosses. Yeah, that's great. So or mentoring, because we're all different. We all have different can I help you get there? Does that mean, okay, you want to want to be? A lot of times, I will do book clubs with people understand why what is their purpose? Why are they in the Six Sigma that'll teach you, you know, thinking about working Again, I try to tailor it to the person and some people have told get an education or anything, but But you need somebody to

Dori Gonzalez-Acevedo: 18:25

Yeah, I like what you're saying. You

Wendy Haines: 18:37

Sure. So I, I've been on the local chapter for campus. And I'm also a committee member for women and quality for 30th annual we have about 1600 people attend. So it's a quite I did help secure the keynote for that event. I'm also on the I'm a reviewer, but I'm on the committee for the international certified toxicologist. So in order to get the 100 continuing I need to demonstrate understanding and learning with The American College of toxicology. So I will be doing communications slash newsletter for women in toxicology. So I'm

Dori Gonzalez-Acevedo: 20:40

similarly to what you were just saying Like, what is it about those experiences that really, you

Wendy Haines: 21:07

I understand that not everybody is an extrovert. A lot of these professional societies, especially the GMP training. But I understand that people want to help, but they may be an put a conference together. Great. And you work for you with ASQ, it's any regulated industry, right, right. Across drug industry, let's say banking, or large equipment, and Okay, and so I always learn, I enjoy also learning. If you can't already tell, yeah, so I recertified for my board But yeah, I just My passion is, you know, how do I connect students or new graduates that are coming into the industry?

Dori Gonzalez-Acevedo: 23:20

Be giving back is also one of the reasons you know, a need and a desire for how to bring women together leading by example. Right, so you like being on these What are some of the things in validation that you think, as we it? Like it's not taught in school? Right,

Wendy Haines: 24:31

right. It's hard because yes, laws do change, but doing paperless validation. And so I think it would behoove About change control, I get that some companies don't. But there's certain pillars of to use Microsoft project that was a beast. Yeah, doing those free trainings like you can go to the Smartsheet website, and Attack toxicologist that does validation. But I have learned I have reviewed engineering plans. Again, I'm not an don't waste your time looking for a solution when you should Thanks, put me to do this. It's a super small site, I'm supposed I'm down. Yes, you are, right, they gave you a job and just with this? Can you point me to where I can maybe get some there's going to be various tools that are going to be management. I've also mentored people too. And they said, know, trying to shift the focus to what is quality metrics here,

Dori Gonzalez-Acevedo: 28:24

safety, efficacy? You know, safety year over year of not questioning and not empowering, Right? Yeah. I mean, the why, and the what you really matter, that or reestablish what is the most critical items that we're effects, you know, throughput, whatever those things are, but new folks empowered enough to be able to come to the table and that haven't been asked? Because everyone's like, looking around,

Wendy Haines: 30:29

Like you said, that's the right questions Sigma certification, whereas the other ones, you have to have a people need to have a better grasp of quality, because And I think if people knew more, whether they were in college, or auditor, or these six sigma belts, so many people are like, how do you broach something

Dori Gonzalez-Acevedo: 31:53

well play into that check? I mean, I teach taught in school, but they're not taught in school. And so we because obviously, there's a lot out there, not every society is

Wendy Haines: 33:01

So I think, Well, what I the advice I give to time for that. I have to write for live in, you know, for work. College of toxicology, I volunteered, and I said, Okay, I And again, it's if it's an area that you want to develop to masses. So I usually recommend communications and some way conferences, full day conferences. Most of the time, people come in, they're like, Okay, we know our date, we know these demands at work. This is the time I can commit. And I No, I don't feel like I can. Right. Right? People have that Yeah. Yeah. I also like part of the in person, I think, I think another one. I, you know, having that in person. Connection is than just virtual events. And I think people also want that I I think, going back to, you know, advice to give to people, bought out whether you're at a drug company, whether you're at very fluid, you can find jobs, and we're all looking for jobs. you have an opening? Or do you know, somebody I can call who your professional development. And that is something that was or company don't count on consultant, right? It's you. And

Dori Gonzalez-Acevedo: 38:19

Yeah, it's a nice balance to be able or professionally are going to change over time, right to have us, right? That we actually have to nurture, right. It's, it's a trajectory I'm on, or I still want to be in the drug industry, dire situation where you've been laid off or whatever, but also, leave the women leading validation?

Wendy Haines: 39:55

With, I would just say because there may be plenty degrees backgrounds that you do, the more you may or may not have don't forget that there's people on the other end and it may be better and my monitor is I want to improve the quality of

Dori Gonzalez-Acevedo: 40:49

It's wonderful. Thank you, Wendy.