The Quality Science Education Certificate 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 that are led by experts who are passionate about your learning.

The Certificate Curriculum At-a-Glance

1. 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.

2. 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).

3. 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.

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

Online through Pathway: Industry Professionals take the Quality Science Education Program through Pathway for Patient Health as an online program. This program is run with a live cohort of industry students who are able to progress through the materials at their own pace, within the timeframes provided in the semester syllabus. The pre-recorded classes are accompanied by study guides and often include handouts and templates to enhance your learning. The Professor (Shannon Hoste) holds live online classes to prepare you for the midterm exam and final exam, engages with you on your ideas and questions, and provides opportunities for industry student presentations. Pathway uses the Canvas Learning Management System for student engagement with course materials, quizzes and exams.

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:

1. Understand why the industry is governed by Good Manufacturing Practices regulations, and how those regulations drive patient and business success.

2. 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.

3. 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.

4. Recognize the significance of the data and studies needed to support product-related decisions made across the total product lifecycle.

Sample Videos:

1. Introduction to the Regulations (27 minutes)

2. Use of Clinical Trial Data (53 minutes)

3. 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:

1. 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.

2. Effective ways to monitor and predict product and process performance.

3. Increasing right-first-time rates through enterprise-wide feedback loops to inform future product development.

Sample Videos:

1. Pharmaceutical Quality by Design - Part 2 (44 minutes)

2. 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:

1. Demonstrate practical use of risk management tools, such as 5 why’s, fishbone diagram, failure mode effect analysis and surveys.

2. 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.

3. Demonstrate the experience gained in class with writing failure investigations that are supported by data and are scientifically sound.

Sample Videos:

1. Failure Investigation Tools - Part 2 (42 minutes)

2. Writing Investigations (31 minutes)

Successful Completion of the Certification

In order to successfully complete the Quality Science Education Certification, industry students:

• Must complete all requirements for each course

• Must receive a grade of at least 70% in each Pathway course. 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 3 courses across any time period that is ammenable to each individual (consecutive semesters, spread out over years, etc.)

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