March / April 2020

A Career of Quality Contributions: 2019 Member of the Year, Charlie Wakeham

2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham

The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.

Charlie, a Regional Informatics Computerized Systems Validation Consultant with Waters Corporation, is a Chartered Engineer and a Fellow of the Institution of Mechanical Engineers. She holds a postgraduate degree in advanced manufacturing technology (with distinction) from the University of Ports-mouth in the United Kingdom. A member of ISPE GAMP® since 1999, she serves on the GAMP® Data Integrity Leadership Team as well as the GAMP® Global Council. She has been a key contributor to documents and guides, and she has offered training and presentations to professionals and regulators around the globe.

Charlie received the ISPE Max Seales Yonker Member of the Year Award at the 2019 ISPE Annual Meeting & Expo in Las Vegas. This award honors the ISPE member who has made the most significant contribution to the Society during the past 12 months.

When Pharmaceutical Engineering® magazine asked her to reflect on the award, Charlie said that “to actually receive the award felt like a vindication, confirm-ing not only that all my personal time working on GAMP® was worth the sacrifices, but also that I was seen as a worthy contributor to the Society. My GAMP® associates have always been tremendously supportive, and I am so fortunate to work with them, but now the wider ISPE community was granting me recognition. The award ceremony may be long over, but the satisfaction and immense gratitude remain.” She also expressed gratitude for the many kind words of congratulations from others in the community. “So many people in my network have reached out to me since the award, and it’s been wonderful to have renewed contact with former colleagues and customers.”

A Personal Commitment to Quality

For Charlie, the production of quality pharmaceuticals is a personal matter as well as a professional vocation. She realized early in her career the centrality of her work to her own well-being, along with that of others.

“The very first process system I ever built was destined for a production line making a medication that I needed then—and still need now. It wasn’t about protecting some faceless end user. If my process system failed, I would suffer the consequences directly. Since then, I have always understood that every action I take must protect patient safety first and foremost.” Today, Charlie remains focused on quality. “I’m at a time of life when a lot of people I know are on blood pressure medications and statins. With concerns about potential carcinogenic effects of nitrosamines in sartans, for example, it all comes down to the fact that you know somebody who might be impacted.”

From Race Car Dreams to Filtration Systems

Charlie’s engineering ambitions weren’t always quite so solemn. As she explained, chuckling, “I graduated university with a bachelor’s degree in me-chanical engineering, a master’s degree in advanced manufacturing technology, and dreams of working on a Formula One racing team.” Soon, however, she realized that those dreams were unrealistic. “You look at the numbers and realize there’s a lot of engineering students and not that many gigs in Formula One.” And even if she were to have landed one, Charlie acknowledged, “it’s also incredibly intense, with weeks and weeks of travel and working through the night. It’s not fame and glory. It’s just insane, hard work.”

As reality set in, she was happy to accept a position with Pall Corporation, where she began building automated filtration systems for pharmaceutical production processes. As a project engineer, she was responsible for the process design, functional specifications, build, testing, and validation of the systems. “That was in 1997, and it was quite soon after that I came across GAMP® 3—a tremendously helpful guide to validating computerized systems, which, strangely, could be read back-to-front and upside down.” In the UK, her career encompassed working with a wide variety of process systems for fixed plants, lab-scale process equipment, filter integrity testers, and single-use bioreactors. When she moved to Australia, she took on a role with Wa-ters Corporation, where she focused on providing validation assistance to regulated customers implementing informatics software, such as the Empower Chromatography Data System used in many quality control labs in the industry.

The work is “not as sexy as Formula One, but I get to contribute to global health,” Charlie said. “It’s a contribution to something that matters. I help pharma make better medicines in order for patients to get better therapeutics.”

Networking, Volunteering, and Learning

Charlie’s relationship with ISPE has spanned 20 years, beginning with her first ISPE conference in 1999. In 2001, she attended the launch of GAMP® 4 and her first GAMP® Forum. In 2003, she volunteered to join a GAMP® Special Interest Group (SIG) on testing GxP systems, and taking on that role was trans-formative. “In reality, volunteering taught me more than I could have learned in 10 conferences, as a SIG comprises industry workers sharing real-life experiences.” According to Charlie, her involvement with ISPE GAMP® over the years has enabled her to have a notable impact within her own company and in the broader industry, with a level of reach that wouldn’t be possible without ISPE.

I help pharma make better medicines in order for patients to get better therapeutics.

Networking has been central to Charlie’s ISPE experience. “I met and forged relationships that are still strong today, such as with Kate Samways, the Testing SIG leader who mentored me through other SIGs and nominated me for my first GAMP® committee, and with Karen Ashworth (a true subject matter expert [SME] in process control systems), with whom I would later co-lead the second edition of GAMP Good Practice Guide: Testing GxP Systems (published 2012) and work on the GAMP® RDI Good Practice Guide: Data Integrity—Manufacturing Records (published 2019). I’ve had the privilege to serve on SIGs and GAMP® committees with so many of the industry’s and ISPE’s great key opinion leaders—Michael Rutherford, Siôn Wyn, Chris Reid, Lorrie Vuolo-Schuessler, to name a few—all of whom have not only been mentors to me but also become personal friends and close colleagues within ISPE.”

Women in Leadership

When Charlie was a university student, she was one of three female engineers in a class of 150 students. “I never felt that being female was a disadvantage,” she recalled. “Although I still occasionally encounter pockets of discrimination, my own experience has been that if you are professional and competent, the discrimination fades away. I do, however, strongly sympathize with women who have faced tougher discrimination challenges.”

Charlie noted that in 2019 the Global Chair and Secretary of GAMP® and the Chair, Co-Chair, and Secretary of GAMP® Americas were all women. This was “not because of any skewed selection criteria, but simply because the committees appointed the competent and willing volunteers best suited to take on the roles at that time,” she explained.

Addressing gender issues more broadly, Charlie said, “I think women are now empowered to enter roles and careers that interest them and, therefore, any prior male bias is ending through natural progression. I do believe, however, that the gender pay gap is a fundamental issue that still needs to be addressed throughout our industry and beyond.”

Composition, Quality, and Integrity

Over the years, Charlie has made her home in a range of locales. “I’ve had the privilege to live in different places through my life—early years in Scot-land and Germany, my school years in the United Arab Emirates, and then my university education and much of my working life were spent in the UK. In 2013, my husband, Kevin, and I, along with our cat, Pippin, emigrated to Australia to explore new horizons.”

The unspoiled scenery of New South Wales inspires Charlie and her husband, both amateur photographers, to practice their hobby. Charlie enjoys nature photography the most. She began taking traditional film photographs at a young age, and transitioned to digital about eight years ago. Whether shooting on film or digitally, her fundamental approach to photography remains the same: “It’s about composing an image that captures the feeling of a moment,” she said. “Composition is the key—it’s what comes in that determines the quality.” Notably, these words about quality in image composition are analogous to Charlie’s principled focus on quality in pharmaceutical manufacturing.

In her interview, Charlie also emphasized the importance of integrity. “Integrity comes from the honesty of the data,” she said. “The oldest maxim in the world is, ‘if it looks too good to be true, it probably is.’”

That’s one of her concerns about digitalization, in both photography and manufacturing. “There’s an immediacy in digital photography versus the de-lay in the old model—with film, you were more or less stuck with whatever you had. But with digital, you can see the result immediately, and you can tweak it. You have the option to fix some of the flaws in the short term, such as underexposure. But I don’t really embrace the massive postprocessing that people do. Images look amazing, but they’ve lost integrity.”

Integrity comes from the honesty of the data.

She expressed similar concerns about data integrity in current pharma manufacturing. “Being able to fix an issue in real time is great, because you should get a much higher yield of quality product. But the concern is that there exists the ability to manipulate the data. There are tremendous benefits in terms of process yield and continual improvement possibilities, but we have to be careful. With improved flexibility comes increased risk to data integrity.”

When thinking about the benefits and potential disadvantages of digitalization, Charlie frames the issue as a generational one. Indeed, as a self-described “midcareer professional,” she seeks to bridge the gap between older and younger workers—and their divergent ways of working. “Veterans of the pharma industry are familiar with working to rigorously defined processes, ‘because that’s how it’s always been done.’ Young Professionals [YPs], especially Millennials, have grown up with supreme flexibility—the ability to instantly bring in a new app to solve a problem; to apply a filter or retake a poor photo—without necessarily being accountable for how changes are made. It will take collaboration between these extremes, facilitated by the mid-career professionals, to fully realize the benefits of digital transformation and to embrace and manage flexibility within a controlled framework.” This collaboration calls for leadership from people who can combine “old school” quality and integrity principles with an understanding of, and an apprecia-tion for, digital agility.

Advice for Young Professionals

Asked to provide some advice to industry colleagues, and especially Young Professionals, Charlie emphasized the importance of volunteering. “You don’t have to be an expert to volunteer, but volunteering can help make you an expert,” she said. “For every guide I’ve worked on, and every conference I’ve been involved with, I have gained more than I have given. In preparing the guide or presentation content, I have improved my knowledge, which I’ve been able to share with my networks. And then these networks put me in contact with more SMEs, and these SMEs often became close colleagues and friends.”

Charlie is dedicated to helping guide younger colleagues. “When I look at the boost to my capabilities, my confidence, and my career that has come from involvement with ISPE, I know I have to pay it forward. So, to all the Young Professionals in ISPE, the first-time conference attendees, and the want-to-be volunteers who feel anxious that they don’t have enough to offer—please speak up, join in, and be part of something special.”

The Path Ahead

“To me,” Charlie said, “The Fourth Industrial Revolution can be simply represented as joined-up thinking supported for the first time by a level of tech-nology interconnectivity and interoperability that allows us to leverage significant process, efficiency, and quality gains.” She described a new era in manufacturing in which the whole picture is visible. “We can see the relationships among the component parts in the process, and the impact any part can have upstream or downstream in that process. For pharma, I believe this provides the opportunity to implement a paradigm focused on maximizing data integrity, product quality, and patient safety. This is a dramatic improvement over the previous focus on compliance for compliance’s sake.”

Despite receiving the Member of the Year Award, Charlie remains humble. “One person changing the industry is a big challenge, and I don’t think I could claim anything close to that. I do hope, however, that the extensive training and consultancy in computerized systems validation and data integrity that I’ve delivered over the years to regulated companies and health authorities across the Asia Pacific region are of value. I hope I have helped raise awareness of the risks to product quality arising from poor data integrity and, in some measure, helped others see the importance of protecting patient safety.”