Corporate Member L&D Site
Quality Science Education Program
Welcome to the Quality Science Education Corporate Membership program! Through your membership, you will find practical education to support your professional development success.
Agreement: Each person has access to the curriculum content during the time of their corporate membership, but may not use the content for purposes outside of learning (e.g. selling workshops, etc.), may not retain copies of the content beyond the membership period, and may not incorporate the content into other programs beyond the membership period. Branding of the content must remain with the content.
What’s New? Check out the Change Control Section of the Class Listing Spreadsheet (below) to see what has been added or if any revisions have been made. [Just see if the version date is newer than when you last checked]
What’s New? Check out the Change Control Section of the Class Listing Spreadsheet to see what has been added or if any revisions have been made since you last checked. —> Class Listing(v21).
The classes have been tagged for job-specific and topic-specific curricula, which allows you to easily identify the classes that will support your success. Enjoy!
As you continue your own career development through the wonderful resources on this Corporate Membership site (see below for courses), consider supporting the next generation coming behind us. Check out our Volunteer Page to learn more about mentoring, teaching, etc., and thank you for your passion to make a difference in this world!
Free Workshops and Webinars
Pathway leads live workshops and webinars that you can join real-time or access later on your own time. These sessions provide insight, successful practices and awareness on critical and timely topics. Check out our Upcoming Sessions and Recordings!
Quality Science Education Courses and Badges
Section 1: Badges
Badges are programs with new content beyond the 3 full Quality Science Education courses listed in Section 4. Pathway continues to build new badges to advance your learning and development. New badges are always underway!
The CAPA Mastery Badge is and Advanced Badge that is intended for those who have already completed the Investigation Series (Basic and Intermediate; or through the Full Risk and Failure Analysis Course). —> Access Series (7 videos)
The Data Integrity Badge is an Advanced Badge that is intended for those who have already completed the Good Documentation Practices course. This badge will prepare the learner with an understanding of data preparation, documentation, management and strategy, —> Access Series (11 videos)
The Inspection Readiness and Management Badge is designed to prepare companies for inspections conducted by global regulatory authorities. The expert instructors provide advanced insights on engaging with regulators, establishing key roles and responsibilities, how to prepare your people, and even how to ensure you have critical inspection rooms logistically set-up for success. —> Access Series (17 videos)
The Software Design Controls Badge is an Advanced Badge that advances through the design controls stages from a software design perspective. The learner will become familiar with V-model and iterative/agile model approaches to leading software design. —> Access Series (11 videos)
The Train the Trainer Badge is ideal for professionals who need to advance their mastery of effective facilitation. This badge encompasses setting the stage, and engaging audiences across different modalities —> Access Series (Setting the Stage: 4 videos; Engaging Your Audience: 6 videos)
Section 2: Topic-Specific Curriculum
These Topic-Specific curricula are classes pulled from the Full Quality Science Education courses (listed in Section 4), and have been organized into focused topics we know are of high interest to the industry. If you have watched the videos in the full courses, there is no need to participate in the courses in this section since these videos came from the full courses.
This introduction to the regulations creates an understanding of why regulations were needed historically, how they guide good business practices, and how they protect patients around the world. However, compliance is not sufficient. Good quality requires critical thinking and an awareness of the big picture impact. The course also addresses global regulatory agencies and harmonization efforts. —> Access Series (16 videos)
The Good Documentation Practices series focuses on ALCOA + principles, how to address documentation failures, and how to find breaches in good documentation practices. —> Access Series (7 videos)
This series on writing investigations includes a basic program and an intermediate program. The programs include exposure to various investigative tools, as well as practical scenarios and critical thinking. —> Access Series (Basic: 12 videos; Intermediate: 7 videos)
This series addresses both fundamental metrics needed to measure performance, but also includes artificial intelligence, culture and creating heat maps. —> Access Series (6 videos)
This series includes a comprehensive view of proactive risk management. A deep dive into the risk management tools for various scenarios gives a hands-on approach to learning practical approaches to risk. —> Access Series (17 videos). [Note: “Reactive” Risk Management is largely covered under the failure investigation classes.]
Section 3: Job-Specific Curriculum
These Job-Specific curricula are classes pulled from the Full Quality Science Education courses (listed in Section 4), and have been organized into focused job-specific concentrations we know can support your growth. If you have watched the videos in the full courses, there is no need to participate in the courses in this section since these videos came from the full courses.
This program groups classes together for the Regulatory Affairs function in pharma, and includes a novice program (14 videos), an intermediate program (15 videos), and an advanced program (10 videos). —> Access Programs
This program groups classes together for the Regulatory Affairs function in medical devices, and includes a novice program (11 videos), an intermediate program (11 videos), and an advanced program (11 videos). —> Access Programs
This program groups classes together for the R&D function in pharma, and includes a novice program (22 videos), an intermediate program (13 videos), and an advanced program (8 videos). —> Access Programs
This program groups classes together for the R&D function in medical devices, and includes a novice program (11 videos), an intermediate program (15 videos), and an advanced program (11 videos). —> Access Programs
This program groups classes together for the Quality Control Analyst function, and includes a novice program (6 videos), an intermediate program (9 videos), and an advanced program (11 videos). —> Access Programs
This program groups classes together for the Manufacturing Supervisor function, and includes an intermediate program (18 videos), and an advanced program (14 videos). It is assumed that a supervisor would not be at a novice level. —> Access Programs
This program groups classes together for the Validation Engineer function, and includes an intermediate program (32 videos), and an advanced program (9 videos). It is assumed that a validation engineer would not be at a novice level. —> Access Programs
This program groups classes together for the Commercial Quality Assurance function in pharma, and includes a novice program (11 videos), an intermediate program (14 videos), and an advanced program (9 classes). —> Access Programs
This program groups classes together for the Commercial Quality Assurance function in medical devices, and includes a novice program (12 videos), an intermediate program (11 videos), and an advanced program (9 videos). —> Access Programs
The Pharmaceutical Operators Program includes topics ranging from GMPs, GDPs, Data Integrity, IQ/OQ, Quality by Design, Validation, CAPA and Post-Market Surveillance so each employee can own the outcome for the company. The series includes a course suggested during the 1st quarter on the production line (Q1 - 14 class), the second quarter (Q2 - 13 classes), the third quarter (Q3 - 15 classes), the fourth quarter (Q4 - 16 classes) and the second year (Year 2 - 19 classes). —> Access Programs
The Medical Device Operators Program includes topics ranging from GMPs, GDPs, Data Integrity, IQ/OQ, Design Controls, Validation, CAPA and Post-Market Surveillance so each employee can own the outcome for the company. The series includes a course suggested during the 1st quarter on the production line (Q1 - 14 class), the second quarter (Q2 - 13 classes), the third quarter (Q3 - 16 classes), the fourth quarter (Q4 - 15 classes) and the second year (Year 2 - 16 classes). —> Access Programs
Section 4: Full Courses
This section includes our 3 Full Courses that address the “why” and “how” we do what we do, in our industry. Since there are 124 videos across these 3 courses, we have also tagged the videos for topic-specific curricula (Section 2) and the job-specific curricula (Section 3) that can help you focus on specific content.
Regulations serve as a foundation for good business decisions that protect and promote patient health. Understanding the “why” of the regulations fosters critical thinking grounded in science, data, stakeholder awareness and regulatory intelligence. —> Access Course (43 videos)
Product, process and specification development are taught, along with concepts such as gap analysis, risk assessment, process characterization, equipment qualification, measurement system analysis, repeatability and reproducibility, and performance qualification/validation. —> Access Course (38 videos)
Risk and failure analysis underpins every decision made in the lifescience 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. —> Access Course (43 videos)
Enroll in a Full Course Today for the upcoming Semester!
If you are interested in enrolling for the upcoming semester, please click here to review the enrollment options and access the Corporate Member Enrollment form. Corporate Member employees receive an 80% discount on tuition!
Technical Support and Questions
If you need technical assistance or have Questions, please complete the following form which will be sent immediately to our Pathway Team. You will be contacted within 1 business day: Technical Support Form