A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom—with input from FDA and other drug and device regulatory agencies—to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.
It has long been a lament in the regulated life sciences industry that quality education results only from on-the-job training and that it takes a long time to mentor and train someone to understand the complexity of assuring product quality. Replacing an experienced professional who leaves or retires is generally challenging.
While the underpinning of the professional staff in product development, scale-up, manufacturing and quality activities is generally a science or engineering degree, the addition of other coursework—for example, covering regulatory requirements, specifications and validation, and risk and failure analysis, among other topics—would greatly enhance a new college graduate’s ability to enter a pharma or medical device company and hit the ground running.
It has long been a lament in the regulated life sciences industry that quality education results only from on-the-job training.
It is also possible that the incidence of some perennial FDA inspection findings such as 21 CFR 211.22 “the quality unit failed…” or 211.25(a) “lack the education, training, and experience, or any combination thereof…” could be lessened by a workforce formally trained in the aspects of quality in a regulated industry.
The curriculum and coursework designed and developed by the CQO team represents a five-course undergraduate minor in quality assurance, designed to complement a science major, and is being made available free to any interested student or university anywhere in the world. The first class is available now, with the others to come in the spring and summer (more on that later).
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Chief Quality Officers Are Prepping the Next Generation of Quality Leaders
The Chief Quality Officers Team was brought together through the efforts of Xavier Health director and former head of quality for Merck’s North Carolina facility Marla Phillips. The team includes the most-senior quality executives from each of the participating companies (see Figure 1), and has recently begun to add their operations peers. The multinational, cross-industry composition of quality leaders was consciously designed to get the most thorough, in-depth thinking and solutions from industries where quality departments operate similarly.
The CQO team was formed in April 2018, with the first face-to-face sessions that October, and convening through virtual and face-to-face forums to “redesign the field of Quality by developing and sharing leading-edge solutions for the benefit of the entire industry and patients around the world.”
Part of the redesign centers around a strong interest and passion in developing the next generation of scientists who enter the pharma and medical device companies in positions across the enterprise, but now have formal education in quality science. Being grounded in quality science enables these students to understand the regulated world they are entering, and to make decisions that lower risk to the product, business and patients they serve.
The goal is to provide a meaningful experience that prepares students to take their place in an industry steeped with rapid innovation.
“In the US, we have not been able to find a school that offers an undergraduate education in quality,” Phillips said. “There are a handful of schools that offer a master’s degree, most of which are heavily focused on regulatory affairs whereas what we are talking about is heavily focused on quality.”
Phillips and her CQO team linked up with the Medical Device Innovation Consortium, or MDIC, which is a public-private partnership that director for the Center for Devices and Radiological Health Jeff Shuren started. MDIC has a “Quality as a Career” team that is focused on providing experiences to undergraduate students that enable them to intentionally choose Quality as a career. These experiences include the Quality Science Education, as well as a standardized approach to internship experiences for companies to adopt. The goal is to provide a meaningful experience that prepares students to take their place in an industry steeped with rapid innovation.
At the Xavier Health Combination Products Summit at Xavier University in Cincinnati, Ohio in mid-September, Phillips hosted a lunch session to update attendees on the CQO’s Quality Science Education (QSE) efforts. Future updates on this and other CQO initiatives will be given by Tony Mire-Sluis (CQO of AstraZeneca), Laura O’Brien (CQO of CSL Behring), and Peter Shearstone (CQO of ThermoFisher Scientific) at the FDA/Xavier PharmaLink conference in March 2020.
Curriculum Developed by Industry and Regulators
The QSE curriculum was developed by industry leaders with input from FDA, Health Canada, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the Health Products Regulatory Authority (HPRA) formerly known as the Irish Medicines Board (IMB).
The goal is to offer the opportunity to science majors—for example, chemistry, biology, engineering, microbiology, or even zoology, or any four-year degree science student. “You can think of this as minor complementing the science major,” Phillips explained. “It includes five courses (see Figure 2) and could constitute a minor, which is a term we use in the United States but is not widely used in other countries.”
The CQO team is working through an organization Phillips created, Pathway for Patient Health (Pathway). Working through Pathway rather than Xavier University allows some creative approaches to be taken through partnerships, as well as accelerating the rate projects can be completed since Phillips can hire resources needed quickly.
“What we will be able to do is certify any university in the world, saying that it has the appropriate curriculum rigor, faculty credentials, and industry involvement,” Phillips said.
The first course is a prerequisite, Phillips explained, “because the students need to understand the legal and regulatory requirements of our industries before they can understand why we validate our products and processes the way we do, why design space and design controls are so critical, etc..” To get an idea of what is covered in the first course, “Global Regulatory and Legal Requirements of Quality,” a set of sample slides is available here.
“We want to assign industry mentors to the students in the area where the student wants to go, but before we do, we need to make sure they feel the curriculum is the right fit for them,” she said. “Because of that, we don’t assign mentors until the students enroll in the second course, which signals that they are serious about the program.”
If the minor program can teach students what quality is all about and include experience in critical thinking and systems thinking, then they can go into industry and immediately make decisions in context.
The next course would cover product development, specifications, validation and controls needed to assure the safety, effectiveness and reliability of the product, and that the product meets the needs of the patient.
“For the risk and failure analysis course, we want the student to take this course as an on-demand course while they are on internship,” Phillips explained. “If you are inside a company for a summer, chances are you are going to see a failure while you are there. This gives the student a chance to see how we recommend investigating a failure and document the findings, what data is needed, what additional information may be needed and how to draw conclusions from the data. It becomes less theoretical if it is done while on an internship. We pull advanced concepts into these courses, including the need to examine why human failure occurs. The root cause isn’t usually human failure, but rather, what process or system failed that led to the failure.”
The three courses in boxes in Figure 2 are industry-related courses that would need to be taught by industry experts. Xavier University is the pilot program that launched in August 2019 as an on-campus program. AstraZeneca will be team-teaching the students in the Spring for the Product Development and Validation course. Alternatively, if a school is not able to identify industry teachers, the content can be provided as an on-demand program that is taught by industry professionals.
The two courses that are not directly industry-related involve business acumen and microbiology. Business acumen is included, Phillips said, because “the quality function is heavily criticized for not understanding the business.”
“Remember that this curriculum is for any science major who could go anywhere in the company, not just quality. Everyone in a company should have some understanding of business and how businesses are run, with a basic understanding of budgets, revenue streams, cash flow, direct and indirect costs, for example.”
The other course that is not industry-specific is microbiology with a microbiology lab. The team developing the QSE felt that a fundamental knowledge of microbiology is important for anyone going into the quality area of a life science company. Phillips maintains that “whether the product being produced is sterile or non-sterile or a medical device or consumer good, it is important to keep microbiological contamination from happening.” If it is not possible for a student to take a microbiology course, Pathway will review and approve an alternate science that is not already part of the student’s major requirements. For more information on the content and length of each of the courses, click here.
With a quality minor in place, “for the first time, a student could intentionally choose a career in quality, instead of it being something that you have never heard of, and once you are in industry you just kind of fall into it,” Phillips emphasized.
She pointed out that if the minor program can teach students what quality is all about and include experience in critical thinking and systems thinking, “Then they can go into industry and immediately make decisions in context, and they can reduce their on-boarding training by as much as one to three years.”
Matching Students and Companies for Internships and Employment
Of fundamental importance to the quality science education effort is the ability for students to take advantage of the newly created minor, and for companies who have a potential interest in those students to be linked together for both internship and employment opportunities.
To that end, Pathway signed an agreement with Quick Base in July 2019 to create a software platform that does just that. The platform is now live.
As a result, industry will have the most up-to-date list of students from universities, including those they do not usually recruit from, who meet their internship and employment criteria (including where they would be willing to live and work in the world), and students will have the most up-to-date reports of opportunities that meet their criteria (such as company, type of internship or employment, location, etc.).
When students enroll in the minor program, each is given a user license in the Quick Base system (“Pathway Portal”). Companies can participate in this program, and have access to students who are gaining the Quality Science Education by becoming members of the Pathway Portal. Membership will begin in 2020 with rates that are based on company size, and gives each company access to all participating students for internships and hire, as well as unlimited access to the course content for current employee education.
Another desired outcome of the effort is paid internships for students enrolling in the program. MDIC has a focus on internships and has worked to create a standardized internship experience for all companies to adopt so students have a great experience.
Phillips said Pathway has reached out to over 90 universities to discuss how they can implement this totally free program for their students. One top question these schools have is how Xavier was able to start the program so quickly since it normally takes a long time to have new courses approved.
Actually, the minor has not been approved yet. Xavier is allowing the course to be taught as an “experimental” course to begin with. However, the process to get the minor approved is underway, and Phillips anticipates approval in “about a year.”
“All of this is free,” Phillips emphasized. “For example, we will give universities professional slide decks, quizzes, homework, and tests that we will help grade.” In order to increase the number of students involved in the program, Pathway is able to directly offer it to any student as a free on-demand certification. This enables the students to join the Pathway Portal and gain opportunities for internships and employment. And with the CQOs of 13 major companies in the life science industries behind the effort, those certificates should help those who have them stand out from their peers when it comes to internship and hiring opportunities.
Voice of the Students
Phillips reached out to some of the students who have decided to take the inaugural first course in the QSE minor program to find out what had attracted them to the program. Below is what they had to say (Figure 3).
Are you a parent of a college science student who might be interested in going through the program? Or a pharma or medical device industry member who thinks your company might want to be able to recruit students from the program? Go to the Pathway website or click here to contact Pathway for Patient Health.
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