Quality Science Education Program Benefits Universities

Universities paving the pathway for immersive internships and employment As a university, you have an opportunity to provide your students with an accelerated pathway into some of the most sought-after industries in the world. Through a free cooperative education model, the health science industries are committed to supporting the success of your students by providing them with access to subject matter expert faculty, immersive educational experiences, and opportunities for paid internships and fulfilling careers.

Learn More Today: Quality Science Education

Free Program

The Quality Science Education Program (QSE) is given free of charge to any university around the world to offer in a manner that is most appropriate for that university. The curriculum has been developed by life science industry and government leaders, and is audited against criteria established by the Pathway for Patient Health Advisory Board. Industry is given visibility to students from participating universities for the purposes of internships and employment. This is a win-win-win for students, universities and industry!

Goal

To accelerate the readiness of your students entering the health science industries by arming them with critical-thinking skills gained through immersion in science-based education and real-world experiences of the 21st century.

Benefits for Your University

1. Complimentary Support and Resources: Pathway for Patient Health will provide subject matter experts to teach any aspect of the curriculum needed by your university, as well as provide direct linkage to internships and co-op opportunities. 2. Increased Student Recruiting: Your university will be able to communicate to prospective families that, through this program, students will be placed on an accelerated path into one of the most in-demand industries in the world. Participating students from universities approved by Pathway for Patient Health will be highly valued and sought after by companies of all sizes and global locations. 3. Increased Employment Rate: Most universities are measured by the employment rate of their graduating students. Students with an education in Quality Science will be directly connected to hiring companies through the Pathway for Patient Health software platform, thus ensuring a heightened rate of post-graduation employment for these students.

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Quality Science Education Program Benefits Universities

The Quality Science Education curriculum has been developed by Pathway for Patient Health through rigorous input from government regulators and industry executives in order to arm your students with the critical thinking skills needed to make scientifically sound quality-based decisions in a world steeped with rapid technological innovation. Industry executives want incoming employees to have this educational focus. In order to equip students with these vital skills, we must ensure that they receive a robust, well-rounded education that leaves them understanding not only the "how" of industry practices, but also the "why." This will ensure that students have the confidence needed to navigate uncharted territory with agility, awareness, and competence. Since the health science industries must be ever vigilant of the impact each decision has on patients around the world, it is time to create the next generation of professionals whose approach will be disciplined, clear, rational, open-minded, and informed by evidence.

Industry subject matter experts are prepared to provide support to your university if and when needed for industry-focused content either through online or on-campus support. Students involved in the Quality Science Education curriculum are prime candidates for global industry internships. These internships offer immersion in hands-on applications of what is being taught in the program and increase the readiness of your students for hire.

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Quality Science Education Program Benefits Universities

How to Get Started

Step 1:

Recognize that Pathway for Patient Health is supporting your ability to offer this program for your students at no cost to you. If desired, industry will provide subject matter experts to help teach the industry-focused content of the curriculum through on-campus or online learning.

Step 2:

Contact Pathway for Patient Health to discuss the curriculum in greater detail. In general, the curriculum desired by industry consists of the following courses:

1. Global Regulatory and Legal Framework of Quality: Following this course, will understand the role of regulators with an overview of regulations as stated in the U.S. Code of Federal Regulations (CFR), EudraLex Directives and Annexes, and Emerging Market regulations for the pharmaceutical, medical device, biotech, animal health and consumer goods industries. The faculty will demonstrate the relationship between regulatory requirements and legal accountability while introducing fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control and validation. Topics such as the role of guidance documents and industry standards will be reviewed, and case studies utilized to support the program. The “why” of the regulations will support the student’s ability to enter the life science industry with an understanding of how to optimize patient health and business success by mobilizing enterprise- wide quality effectiveness through innovative systems and critical thinking grounded in science, data, stakeholder awareness and regulatory intelligence. 2. Business Acumen: In the life science industries, many functional area employees are criticized for not understanding the business within which they operate. Undergraduate science majors who enter these industries with a balanced understanding of science and business will increase the effectiveness of their work, and the success of their company. This Business Acumen course will cover key financial concepts and applications, such as operating and capital expenses, fixed assets and liabilities, cash flow, profit and net worth. Most universities will already have a course that covers these concepts and would therefore fulfill this course requirement. In support of the university business course, industry subject matter experts can provide insight on how a strong culture of quality drives business success. 3. Product Development, Specifications, Process and Validation: In this course students will be exposed to the major design processes that are critical to life science product, process and specification development. Topics to be covered include cradle to Page 3 of 5

Quality Science Education Program Benefits Universities

grave product and process development, prototype builds, scalability, design of experiments, variability, control, specification development, and validation methodology. Instructors will explore how rigorous human factor engineering studies and clinical trials provide essential inputs into the product development process. The students will be introduced to concepts such as gap analysis, risk assessment, master plan, process characterization, installation qualification, operational qualification, measurement system analysis, repeatability and reproducibility (data collection / analysis), and performance qualification/validation. In a world of innovative technology, it is critical that the students gain an understanding of computer system and software validation to ensure the quality of data generation, data storage, and digital processes used in manufacturing and products with digital components using technical and practical aspects expected in the regulated life science industries. 4. Risk and Failure Analysis: Although risk and failure analysis is currently taught at many universities, this course will dive into the nuances of the life science industries related to the specific regulations that apply to consumer health products. Importantly, it is desired that students take this course while on internship at a life science company such that they can experience a failure while learning all that is required for acceptable resolution. Through the use of historical risk analysis techniques, such as FMEA, Fault Tree, and 5 Why’s students will be able to analyze a holistic set of data (in- production, across product lines, across equipment, human variability, on-market, on-stability, validation studies, change control, etc.) that will lead to scientifically justified investigations supported by evidence, and the identification of effective corrective and preventative actions (CAPA). 5. Microbiology Course: Life science industries are expected to limit or eliminate the potential for microbiological contamination in consumer health products. In order to achieve this goal, it is beneficial for all scientists entering these industries to understand the concepts and principles of microbiological identification, testing, and control. This course requirement could likely be fulfilled through the standard university-offered microbiology course, and could be supported by industry subject matter experts to explain challenges experienced in industry settings, as well as successful practices. 6. Microbiology Laboratory: In order for students to better understand how to identify, test and control microbiological contamination in consumer health products, the laboratory course will cover topics such as aseptic technique, media preparation growth promotion, sterility, isolation, identification limitations, action limits, specifications, and environmental monitoring within the regulatory framework of the life science industries. This laboratory course requirement could likely be fulfilled through the standard university-offered microbiology laboratory course, and could be

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Quality Science Education Program Benefits Universities

supported by industry subject matter experts to explain successful techniques that meet regulatory requirements.

Step 3:

Determine how to implement the curriculum in a way that best fits your academic model. Your model might result in offering the above listed courses a Minor in Quality Science, or as a certificate of stand- alone courses that students can take as electives. Your school may or may not involve co-op assignments, etc. When assessing the curriculum, note that it is likely your already-established business and microbiology courses will fulfill the content desired by industry. Pathway for Patient Health will certify the rigor of your curriculum, the credentials of your faculty, and the success of your students according to criteria established by the Advisory Board.

Step 4:

Engage with Pathway for Patient Health to register your university as a participating school that can be supported by industry. Once certified, your students will be given visibility to participating companies for paid internships and possible employment through a proprietary software platform.

GET STARTED TODAY!

Contacts: ● Ann Hinkle, Director of University Relations [email protected] | 513-320-3884 ● Marla A. Phillips, Ph.D. CEO Pathway for Patient Health [email protected] | 513-238-4338 ● Michael J. Mascali, R.Ph. COO Pathway for Patient Health [email protected] | 216-401-1822

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