Biotechnology Innovation & Regulatory Science Professional Certificate
In the rapidly evolving field of Biotechnology Innovation and Regulatory Science (BIRS), ensuring quality is not merely a goal but a necessity. This program provides the tools and knowledge necessary to navigate and succeed in a field where quality is the cornerstone of innovation and regulatory compliance. This educational journey prepares professionals so they can advance the frontiers of biotechnology while adhering to the highest standards of quality and regulatory rigor.
Are you working in pharmaceutical, medical device/diagnostics or other highly regulated biotechnology industries? Are you ready to take the next step in your career? Equip yourself with tools to tackle challenges and gain an invaluable network of professionals to lean on and learn from.
- Understand the current topics/issues facing the industry today
- Learn more about the industry with low-stake assignment practice opportunities
- Learn about multiple areas of biotechnology product manufacturing and regulation
- Gain an opportunity to network
The BIRS program is introducing a professional certificate. You have the flexibility to determine if you want to take one course for personal enrichment or complete all three courses for a BIRS Professional Certificate. The full certificate will take one year to complete. Participants could opt to apply the credits to the MS hybrid program once certain requirements are met.
LEARNING ENVIRONMENT
We try to maximize opportunities for every participant to learn, grow, and succeed in reaching the course outcomes, and reach their personal goals and desires related to the class. We draw on theory, frameworks, and practices rooted in principles of collaborative learning and student-faculty partnership. We focus on student learning, which we define as a process of individual change. This means developing skills to view the world in new ways, and engaging in different types of debates, discussions, and dialogues.
A combination of participation, such as case studies, discussions, projects, readings (articles and primary literature), and relevant videos may be used as supplemental information. Activities will be scaffolded with opportunities to practice knowledge.
This program will give you access to lecturers who are leaders in their field via our virtual learning sessions hosted on Friday’s from 11:30 – 1:00 p.m. (ET). Attending the sessions provides you with opportunities to engage, ask questions from the guest speakers, and interact with other participants in a global forum.
REGISTER TODAY - Registration link coming soon!
Courses range from $2,500 to $2,750, depending on the path you select.
Refer to the chart to gain a better understanding of the course expectations for each option.
| Course Assignment Expectations | |
| $2500 Noncredit Assignment Expectations | $2750 Credit Pathway Assignment Expectations |
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Classes begin every August, January, and May.
If you complete all three courses, you will receive a BIRS Professional Certificate.
Email birs@purdue.edu with any questions.
PROFESSIONAL CERTIFICATE COURSES
- Drug Development: A review of drug discovery and drug development, with emphasis on the regulatory aspects of these activities. Animal preclinical research and human clinical research are discussed in detail. In addition, the process for the assembly of an IND and NDA is discussed along with the Phases (I, II, III) of human clinical trials. The CMC (chemistry manufacturing and control) aspects of drug development are presented along with ICH documents and manufacturing process analytical technologies. The course concludes with a brief review of international regulatory issues and patents. (3 credits – Fall Semester)
- Good Regulatory Practices: Includes a review of the FDA and ICH regulations on good manufacturing, good laboratory, and good clinical practices. The meaning of these regulations, the globalization of practices, and the roles and responsibilities of various professionals implementing these regulations are addressed. Special emphasis will be detailed coverage of the process for the assembly and submission of an IND or NDA, and the function of the regulatory affairs department in a pharmaceutical company. (3 credits – Spring Semester)
- Quality Management, Audits & Inspections: Advanced topics in quality management and business improvement methods that apply to the pharmaceutical industry. Emphasis is placed on specific issues of industry audits and inspections, as well as successful selection and presentation of business and quality improvement projects. (3 credits - Summer)
Complete all three of the hybrid courses, Drug Development, Good Regulatory Practices, and Quality Management, Audits & Inspections and you will receive a personalized BIRS Professional Certificate in addition to personalized certificates for each individual course.
Frequently Asked Questions
What is the difference between noncredit and credit classes?
Credit courses are usually taken to work towards a degree program. Non-credit courses are taken for personal or professional interest and do not usually offer college credit.
However, there is a noncredit-to-credit pathway for students who complete the full certificate program (all three courses: Drug Development, Good Regulatory Practices, and Quality Management, Audits & Inspections).
How does the noncredit-to-credit pathway work?
Upon satisfactory completion of the full certificate program (Drug Development, Good Regulatory Practices, and Quality Management, Audits & Inspections), students will have the option to apply all the courses to Purdue University’s Biotechnology Innovation and Regulatory Science MS concentration once certain requirements are met. For more information about the MS concentration, see here.
What will I learn if I enroll in the noncredit-to-credit program?
This program is designed to provide professionals education in the important aspects of biotechnology innovation within the context of regulatory compliance and quality assurance. This program will blend scientific content knowledge with professional skills.
The curriculum focuses on advanced topics such as drug development, good regulatory practices and quality management. Concepts gained with this certificate include drug development, quality & productivity principles.
What is the learning approach?
We try to maximize opportunities for every participant to learn, grow, and succeed in reaching the course outcomes, and reach their personal goals and desires related to the class. We draw on theory, frameworks, and practices rooted in principles of collaborative learning and student-faculty partnership. We focus on student learning, which we define as a process of individual change. This means developing skills to view the world in new ways, and engaging in different types of debates, discussions, and dialogues.
What is self-guided and self-paced class?
While due dates will be provided to keep participants on track, students can choose how much or how little time to spend on course readings, discussions, and assignments each week. This is intended to provide students with the flexibility needed to make the course work for their individual circumstances. In addition, the course won’t be actively driven by the instructor. Students will find everything they need to understand the course content, discuss, and evaluate their learning within the Brightspace page. However, a member of the leadership team will periodically monitor the course, and will be available if any students need assistance.
You are responsible for your own progress!
What is the cost of enrolling in the Biotechnology Innovation and Regulatory Science non-credit program?
The cost of the program is dependent upon your goals.
- $2500 – Noncredit (Personal enrichment.)
- $2750 - Credit Pathway (Plan to use credits toward the MS concentration in Biotechnology Innovation and Regulatory Science.)
The table below provides the course expectations for each option.
| Course Assignment Expectations | |
| $2500 Noncredit Assignment Expectations | $2750 Credit Pathway Assignment Expectations |
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How long will I have access to the course(s)?
Students will have sixteen weeks of access to each course that is purchased individually. Twelve weeks for the summer session.
How much time should I allow for doing the readings and completing assignments?
This course is similar to a standard 3 credit hour class, meaning that students should expect to spend 6 -9 hours per week to complete each course (all three courses: Drug Development, Good Regulatory Practices, and Quality Management, Audits & Inspections) in 16 weeks (12 weeks summer). However, because the course is self-paced, students can decide how much time to allocate to the learnings each week. Students will have 16 weeks to complete each course with the exception of the summer course. The summer session runs 12 weeks.