Earn an Advanced Certificate in Biomedical Quality Systems from San Diego State University. You’ll learn how to ensure that products are safe for consumers by focusing on quality assurance and regulatory compliance in the biopharmaceutical, medical device, and pharmaceutical industries.
About the program
Created in collaboration with SDSU’s College of Sciences, the Advanced Certificate in Biomedical Quality Systems (BQS) is one of the very few quality management programs with a special emphasis on biomedical quality in the nation. It’s designed to help current and future working professionals develop an advanced knowledge of the practices and principles of quality management in the biomedical industry. If you’re passionate about regulatory compliance and bringing safe products to market, this four-course graduate-level certificate program will prepare you to take on more advanced roles in your organization.
Your instructors are world-renowned subject matter experts and leading industry professionals with international awards and highest certifications from the American Society of Quality (ASQ). They teach a curriculum that’s continuously updated with the latest rules, regulations, and industry standards from the Food and Drug Administration and its international counterparts, which means that you’ll get an education that prepares you for today’s job requirements.
Meet Your Program Director
Dr. Gurpreet Singh, Ph.D., ASQ-MBB, CPSM, CPSD, C.P.M. is an international award-winning thought leader, consultant, entrepreneur, author, coach and educator. He’s also the founder and head of the consulting firm Strategic Supply Chain & Six Sigma Consulting LLC.
Dr. Singh is a designated Certified Purchasing Manager (C.P.M.), Certified Professional in Supply Management (CPSM), and a Certified Professional in Supplier Diversity (CPSD) having achieved all these designations from Institute for Supply Management (ISM). He was the recipient of the “ASQ Armand Feigenbaum Medal” for 2015, as well as the “ISM Education Person of the Year Award” in 2009 and with “Ray Clapton C.P.M. Award” in 2010. Dr. Singh was also honored with “ISM J. Terry Leadership Person of the Year” in 2014.
Program is perfect for
SDSU’s online BQS Certificate program is designed for early- and mid-career working professionals who hold bachelor’s degrees and want to take on more advanced leadership roles in the biomedical industry. BQS Certificate holders will learn how to:
- Solve problems by applying quality principles and tools
- Explain various quality tools and concepts
- Attain a mindset of Operational Excellence
- Lead Teams and Direct Change
- Understand FDA and International Regulations
- Develop processes that are under control and can be measured
The program is ideal for prospective graduate students who want to earn their master’s degree in regulatory science, quality management, or any related field. If you’re interested in earning a Master’s in Regulatory Affairs with San Diego State University, you can apply all twelve units earned in the advanced certificate program to SDSU’s master’s degree program as elective course units.
The program is also designed to prepare you for professional certification exams with the American Society of Quality (ASQ). ASQ-certified quality professionals are better equipped to ensure that regulatory requirements are being met and quality standards are upheld throughout the manufacturing process.
What you can learn
SDSU’s Advanced Certificate in Biomedical Quality Systems is designed to give you a foundational knowledge of the principles and practices that go into the safe development, testing, and manufacture of pharmaceutical, biopharmaceutical, and medical device products. The curriculum also provides additional training to help you ensure that products are in full compliance with current regulatory requirements.
You’ll gain an international view of the biomedical industry and Safe Medical Devices Act from a quality perspective. The program covers practical skills, approaches, and solutions related to:
- Operational Excellence & Quality Organization
- Leadership & Change Management
- Lean and Six Sigma
- Risk Management & Change Control
- Auditing, Compliance & Documentation
The BQS program consists of four courses:
- Biomedical Quality Systems 601 covers the organizational philosophies, structures, and different active roles of international regulatory agencies.
- Biomedical Quality Systems 603 is designed to present the major elements and principles of the international quality systems used in the development and commercialization of biomedical products.
- In Biomedical Quality Systems 730, students learn the major elements and principles of the international regulations governing the development and commercialization of biomedical products.
- Biomedical Quality Systems 745 will ensure that students build a foundational and practical knowledge in quality systems and biomedical regulations related to major elements and principles of international regulations governing control of data, documents, information, and records associated with biomedical products.
All four courses are delivered in nine-week sessions. Courses are scheduled synchronously, which means that you’ll have the same classmates throughout the program. Assignments have set due dates, but most lessons are pre-recorded, which means that you’ll be able to view your lessons and complete assignments on your schedule, which is ideal for working students with full- or part-time jobs.
Your instructors are faculty members from SDSU’s College of Sciences, all of whom are fully certified by the American Society for Quality (ASQ). Many instructors also have extensive professional experience with manufacturing and regulatory affairs. Through their expertise, you’ll examine issues relating to quality control and quality assurance from an industry insider’s perspective.
If you’re interested in earning your master’s degree, you can apply three (3) out of the four (4) courses in the BQS Certificate program to the M.S. in Regulatory Affairs degree as electives.
Last 12 months
Over 10 years
Source: BLS & Burning Glass Technologies, 2020
In the past year, there were nearly 46,000 job postings for quality control systems managers across the country. Quality control systems managers earn a median annual salary of $78,000, which is highly dependent on qualifications, experience, and education level. The median annual salary for those who hold an associate’s degree is $62,800; for a bachelor’s degree, $81,900; and for a master’s degree, $83,700. Individuals with over 9 years of professional experience can earn more than $106,000 per year.
Why Should You Choose Us?
SDSU’s BQS Certificate program is designed to meet the demand for management-level quality assurance professionals. The curriculum is continuously updated with the latest regulatory standards. The program provides a unique opportunity for prospective graduate students to build an advanced foundation of quality systems and assurance, while also preparing for ASQ certification exams.
BQS Certificate faculty members are all fully ASQ-certified. Many instructors also have extensive professional experience in biomedical manufacturing and similar fields, which means that they’re in tune with the most up-to-date regulatory requirements, protocols, and industry standards.
Enrolling in SDSU’s program means that you can earn your BQS Certificate without ever attending an in-person class on a college campus. The curriculum is 100% online, which means that you can take these quality management courses without sacrificing your professional responsibilities.
In order to earn your Advanced Certificate in Biomedical Quality Systems, you must complete the following four courses:
BQS 601: Biomedical Quality Systems (3 Units)
Global view of biomedical industry and Safe Medical Devices Act from quality perspective to provide foundation in the field of biomedical quality systems.
BQS 603: Foundational Quality Systems (3 Units)
Roles and responsibilities of a typical quality assurance (QA) department in biopharmaceutical, medical device, and pharmaceutical industries. Practical skills, approaches, and solutions to multifaceted auditing, change control, compliance, documentation, laboratory, material, and production control issues.
BQS 730: Good Manufacturing, Laboratory, and Clinical Practices (3 Units)
Roles and responsibilities of a Quality Assurance (QA) function in the biopharmaceutical, medical device, and pharmaceutical industries. Equip middle and upper level biomedical professionals with “real world” skills, approaches, and solutions to multifaceted quality issues.
BQS 745: Document Control Quality System (3 Units)
Regulatory requirements for developing and manufacturing documentation, supporting the quality assurance function.
In order to successfully apply for the Advanced Certificate in Biomedical Quality Systems program, you must meet all the minimum SDSU requirements, at the time of enrollment:
- You must hold an acceptable baccalaureate degree earned at an institution accredited by a regional accrediting association, or have completed equivalent academic preparation as determined by the graduate dean
- You must have attained a grade point average of at least 2.85 in an acceptable earned baccalaureate degree, or at least 2.85 in the last 60 semester (90 quarter) units attempted, or hold an acceptable post-baccalaureate degree earned at an institution accredited by a regional accrediting association
- You must have been in good standing at the last institution attended
- You must have achieved satisfactory scores on all sections of the GRE for degree seeking applicants.
To apply for the Advanced Certificate in Biomedical Quality Systems, you must complete the following steps:
- Apply to the University through Cal State Apply
- Create your SDSU WebPortal Account after receiving your Red ID number
- Submit Official Documents to Graduate Admissions, which include:
- Official transcripts (in sealed envelopes) from all postsecondary institutions attended
- Students who attended SDSU need only submit transcripts for work completed since last attendance
- Students with international coursework must submit both the official transcript and proof of degree. If documents are in a language other than English, they must be accompanied by a certified English translation.
Official documents should be mailed to:
San Diego State University
5500 Campanile Drive
San Diego, CA 92182-7416
- Submit Official Documents to SDSU’s Center for Regulatory Science, which include:
- Résumé or curriculum vita (CV) listing employment or volunteer experience relevant to the program
- One set of official transcripts (in addition to those sent to Graduate Admissions).
Official documents should be mailed to:
Biomedical Quality Systems Certificate
Director of Regulatory Affairs Programs
San Diego State University
5500 Campanile Drive
San Diego, CA 92182-1010
Total Units: 12
Total Cost to Complete Program: $8,388