BIOTECHNOLOGY QUALITY AND
REGULATORY COMPLIANCE
This new graduate certificate in the College of Technology is designed to provide professionals graduatelevel education in the important aspects of biotechnology innovation within the context of regulatory
compliance and quality assurance. The graduate certificate is a nice compliment to undergraduate and
postgraduate degrees.
The graduate certificate can be earned in four semesters upon successful completion of the required
coursework. Participants take one course per semester in this program.
Admissions requirements
Students must meet the following admission requirements for the graduate certificate program:
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Bachelor’s degree from an accredited institution
Minimum undergraduate GPA of 3.0/4.0 (consideration will be given for relevant work experience)
Two letters of recommendation will be required if the undergraduate GPA is below the 3.0/4.0
requirement
Minimum TOEFL iBT score of 77 if student is not from an English Speaking Country
(http://www.gradschool.purdue.edu/admissions/apply_countries.cfm).
Recommendation by the department's admissions committee and approval by the Graduate School
Applications should be received by the Graduate School by July 15 for admission for Fall semester, by
November 1 for Spring semester, and by April 1 for Summer semester.
We recommend that, if you are employed, you talk first with your supervisor concerning participation in
the program.
Required Courses
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TLI 521 Drug Development
TLI 522 Good Regulatory Practices
TLI 523 Quality Management, Audits and Inspections
TLI 525 Molecular Basis of Manufacturing
(The graduate certificate program does not serve as a stepping-stone to the MS Biotechnology Innovation
and Regulatory Science (BIRS) concentration. Only two of the graduate certificate courses will transfer
to the MS concentration in Biotechnology Innovation and Regulatory Science.)
How to apply
Use the Purdue University Graduate School's online application system at
http://www.gradschool.purdue.edu/ and click on the “apply now” button.
For more information, contact:
Mary Speer, Program Manager, mspeer@purdue.edu
Tuition and fees
Tuition and fees are $1,000/In State and $1,030/Out-of-State per credit hour. This includes costs for
Friday dinner, Saturday breakfast and lunch and books. Tuition and fees must be paid prior to the
beginning of each academic semester. Students will be responsible for their housing. For students
attending classes in West Lafayette, a hotel room block will be reserved, and hotel information will be
sent upon enrollment. Students are welcome to utilize the room block or find other accommodations.
Students might also be eligible for tuition reimbursement if certain conditions are met within their
company. For additional information about tuition reimbursement, interested individuals should contact
their Educational Assistance Plan Administrator within their organization.
Course formats
The BQRC courses are offered in a blended format. Typically the more basic information is presented
online and advanced material, difficult concepts and group projects are presented on weekends. The
courses are presented on weekends (three weekends per semester) at Purdue University, West Lafayette,
Indiana. Participants attend class from 6 – 9 p.m. Fridays and 7:30 a.m. - 2:30 p.m. Saturdays or from
2:30 p.m. – 5:00 p.m. Saturday and 7:30 a.m. - 2:00 pm on Sundays. This will be determined prior to
each semester.
GRADUATE CONTACT
Mary Speer