The Quality Science Education Curriculum is rich with in-depth industry experience, insight, knowledge and case study examples. This one-of-a-kind program includes 3 industry-developed courses, as well as 2 courses students take through their schools (which may be waived upon approval for students already working in industry).
The Micro-Credential Curriculum At-a-Glance
Global Regulatory and Legal Requirements of Quality. (No Pre-requisite). 3 credit hour Pathway-Developed Course. This course is focused on “why” global regulations were adopted, and the evolution of the quality systems grounded in science.
Product Development and Validation. (Prerequisite: The Global Regulatory and Legal Requirements of Quality course). 3 credit hour Pathway-Developed Course. This course is divided into 3 parts: pharmaceutical validation, medical device design controls, and emerging technology (such as 3D printing, cell/gene therapy, and artificial intelligence).
Risk and Failure Analysis. (Prerequisite: The Global Regulatory and Legal Requirements of Quality course). 3 credit hour Pathway-Developed Course. This course is divided into 2 parts: how to design risk out of your product to begin with, and how to investigate failure if/when it occurs. This course introduces students to the investigation processes and writing scientifically justified conclusions linked to true root cause.
Business Acumen. Students are required to take a semester-long business course through their school. Pathway will work with the students to determine if previously taken courses qualify, or to determine which courses will quality. It is not the intent of Pathway that the students take business courses with prerequisites, but rather, to take a course that exposes students to business concepts such as operating and capital expenses, fixed assets and liabilities, cash flow, profit and net worth. This requirement may be waived for students who are already working in industry.
Microbiology and its Laboratory. Students are required to take a semester-long microbiology course through their school. However, if microbiology is not possible, then Pathway will work with the students to identify other non-major sciences that may be deemed relevant. Students who have taken microbiology at some point in their student career will likely have fulfilled this requirement. This requirement may be waived for students who are already working in industry.
Questions? Please contact Ann Hinkle, Director of University Relations and Enrollment, at Ann.Hinkle@QualityChampions.org.
Pathway Academic Calendar
To download the full Pathway Academic Calendar, which includes Semester Enrollment Dates and Semester Start/End Dates through 2028, click on the icon.
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How the Program is Offered
Xavier University Students enjoying the Program as they are taught by AstraZeneca on campus
Online through Pathway: Students may take the Quality Science Education Program through Pathway for Patient Health as a free online, pre-recorded program (as long as they are formally enrolled in a school/university when Pathway classes begin). This program is run with a live cohort of students. The Professor holds live online classes to prepare for the midterm exam and final exam, engages with students on ideas and questions, and may provide opportunities for live industry sessions. Pathway uses the Canvas Learning Management System for student engagement with course materials, quizzes and exams.
Through Universities: Students may take the Quality Science Education Program through their schools for academic credit, if their school is participating in the program. If you are unsure if your school is offering the program for academic credit, please Contact Us so we can help.
Industry Professionals: If you are an industry member interested in the Quality Science Education micro credential, please checkout the Industry Curriculum, or Contact Us so we can discuss your specific interests and situation.
Detailed Curriculum and Sample Class Videos
Course 1: Global Regulatory and Legal Requirements of Quality
Description: (No Pre-requisite). 3 credit hour Pathway-Developed Course. Regulations serve as a foundation for good business decision that protect and promote patient health. Faculty demonstrate the relationship between regulatory requirements, legal accountability and business responsibility, while introducing fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, change control and validation. Topics such as the role of guidance documents and industry standards are reviewed, and case studies utilized to support the program. Understanding the “why” of the regulations foster critical thinking grounded in science, data, stakeholder awareness and regulatory intelligence.
Learning Objectives: By the end of the Global Regulatory and Legal Requirements of Quality course, students will be able to:
Understand why the industry is governed by Good Manufacturing Practices regulations, and how those regulations drive patient and business success.
Identify risks associated with medical device, drug and human factors risks in order to, for example: (a) design process controls to reduce risk to product quality, (b) determine the correct classification of medical devices in order to design an appropriate development strategy, (c) identify primary and secondary clinical trial targets to demonstrate product safety and efficacy, and (d) understand risk to product on the market related to manufacturing failures.
Describe the medical device and pharmaceutical Quality Systems, and how those systems enable organizations to consistently produce products that are of the purported quality and safety, and meet user needs.
Recognize the significance of the data and studies needed to support product-related decisions made across the total product lifecycle.
Sample Videos:
Introduction to the Regulations (27 minutes)
Use of Clinical Trial Data (53 minutes)
Quality for the 21st Century - Culture (36 minutes)
Course 2: Product Development and Validation
Description: (Prerequisite: The Global Regulatory and Legal Requirements of Quality course). 3 credit hour Pathway-Developed Course. Major design processes that are critical to life science product, process and specification development are explored in this course. Topics covered include: product and process development, design of experiments, variability, control, and validation methodology. Participants learn how rigorous human factor engineering studies and clinical trials provide essential inputs into the product development process. The participants are introduced to concepts such as gap analysis, risk assessment, process characterization, equipment qualification, measurement system analysis, repeatability and reproducibility, and performance qualification/ validation.
Learning Objectives: By the end of the Product Development and Validation course, students will be able to:
Describe what needs to be studied and demonstrated during medical device and drug product development, from process controls, safety, efficacy, function, stability, scale-up, process validation and test method validation.
Effective ways to monitor and predict product and process performance.
Increasing right-first-time rates through enterprise-wide feedback loops to inform future product development.
Sample Videos:
Pharmaceutical Quality by Design - Part 2 (44 minutes)
Medical Device Risk Management (51 minutes)
Course 3: Risk and Failure Analysis
Description: (Prerequisite: The Global Regulatory and Legal Requirements of Quality course). 3 credit hour Pathway-Developed Course. Risk and failure analysis underpins every decision made in the life science industries. In this course, participants will be exposed to the use of risk analysis proactively to inform product development, as well as reactively to find true root cause to product, process and system failures. Through the use of historical risk analysis techniques, such as FMEA, Fishbone, and 5 Why’s, participants are 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 lead to scientifically justified investigations supported by evidence, and the identification of effective corrective and preventative actions (CAPA).
Learning Objectives: By the end of the Risk and Failure course, students will be able to:
Demonstrate practical use of risk management tools, such as 5 why’s, fishbone diagram, failure mode effect analysis and surveys.
Assess a failure situation for root cause, impact to product (in production and on-market), trends, and corrective/preventative actions that will be effective at preventing recurrence.
Demonstrate the experience gained in class with writing failure investigations that are supported by data and are scientifically sound.
Sample Videos:
Failure Investigation Tools - Part 2 (42 minutes)
Writing Investigations (31 minutes)
Successful Completion of the Micro Credential
In order to successfully complete the Quality Science Education Micro Credential, students:
Must complete all requirements for each course
Must receive a grade of at least 70% in each Pathway course, and receive a passing grade on the courses taken through their university. If a grade of 95% or higher is achieved in all 3 Pathway courses, then the student will receive their certification with honors.
May complete the program throughout their academic career. As long as the student remains a student (even if transitioning from undergraduate to graduate school), the student will be deemed “active” in the program.
Submit transcripts to Pathway to demonstrate the successful completion of all non-Pathway courses that are part of the program.
Upon successful completion of the program, students may include the following designation after their names: CQSP - Certified Quality Science Professional.
Enroll today, and let us support your success!
If you have any questions, please contact Ann Hinkle, Director of University Relations and Enrollment, at Ann.Hinkle@QualityChampions.org