Program Overview
Through four graduate-level courses, students gain knowledge in product approval, GMP practices, quality control, and facility design. Graduates are prepared for careers in regulatory affairs, quality assurance, and other related fields in the biotechnology and pharmaceutical industries.
Program Outline
Outline:
Content:
The Professional Studies Post Baccalaureate Certificate in Biochemical Regulatory Engineering offers a deep dive into the complexities of product approval and ensuring regulatory compliance for biopharmaceutical products. Through four meticulously designed courses, students acquire knowledge and skills to navigate the intricacies of the FDA process effectively.
Structure:
The program comprises four graduate-level courses totaling 12 credits. Each course emphasizes a distinct aspect of the regulatory landscape in the biopharmaceutical arena.
- BTEC 660 - Development and Regulation of Biopharmaceuticals: Explores essential regulatory requirements applicable to biopharmaceutical research, development, and commercialization.
- BTEC 662 - Good Manufacturing Practices for Bioprocesses: Equips learners with fundamental principles of ensuring quality and compliance throughout the life cycle of biotherapeutic products.
- BTEC 664 - Quality Control and Quality Assurance of Biotechnology Products: This course covers best practices, methodology, documentation, and regulatory considerations pertinent to maintaining high quality standards in biotechnology products.
- BTEC 666 - Biotechnology GMP Facility Design, Construction and Validation: Provides insight into constructing and validating facilities dedicated to biopharmaceutical products, ensuring alignment with stringent regulatory guidelines.
Schedule:
Each course is typically offered as one- or two-day intensive modules conducted in either an online synchronous format through video conferencing technology or in-person at UMBC or designated off-site locations.
Careers
Graduates are well-positioned for diverse opportunities within biotechnology and pharmaceutical industries or related fields associated with regulatory affairs for biotherapeutics. The acquired expertise empowers them to pursue various careers like:
- Regulatory Affairs Associate
- Biopharma Product Management Specialist
- Regulatory Compliance Analyst/Manager
- Quality Control/Quality Assurance Lead
- Process Validation Specialist
Other:
- Students have the flexibility to apply the 12 credits earned in this certificate toward the Master of Professional Studies (M.P.S. ): Biotechnology degree.
- All course instructors possess a unique blend of academic credentials and extensive real-world industry experience, ensuring practical and up-to-date expertise.
University of Maryland, Baltimore County (UMBC)
Overview:
UMBC is a public research university located in Baltimore County, Maryland. It is known for its commitment to undergraduate teaching, innovation, and diversity. UMBC offers a wide range of academic programs, including undergraduate and graduate degrees, as well as professional master's programs.
Services Offered:
UMBC provides a comprehensive range of services to its students, including:
Admissions & Aid:
Undergraduate and graduate admissions, professional programs, financial aid, and scholarships.Academics:
Degrees and programs, colleges and departments, undergraduate and graduate catalogs, academic support, and academic calendar.Research:
Research and creative achievement, faculty experts, library resources, undergraduate and graduate research opportunities, and faculty research opportunities.Life on Campus:
Campus life overview, arts and culture, athletics and recreation, clubs and activities, events, health and well-being, and residential life.Giving:
Make a gift online, giving to UMBC, support student projects, and alumni community.Other:
myUMBC portal, directory, campus maps and location, on-campus destinations, where to eat, contact us, career center, events, mobile apps, stories, visit campus, work at UMBC, online directory, emergency info, and UMBC police.Student Life and Campus Experience:
UMBC offers a vibrant campus life with a strong sense of community. Students can participate in a wide range of activities, including:
Arts & Culture:
Attend events at the university's arts venues and engage with the creative arts community.Athletics:
Cheer on the Retrievers, UMBC's athletic teams, and participate in recreational activities.Clubs and Activities:
Join student organizations and clubs that align with their interests.Events:
Attend various events and programs hosted by the university throughout the year.Health and Well-being:
Access resources and support services for physical and mental health.Residential Life:
Live on campus and experience the benefits of a close-knit community.Key Reasons to Study There:
Strong Academic Reputation:
UMBC is recognized for its high-quality academic programs and its commitment to undergraduate teaching.Innovative Research:
The university is a leader in research and innovation, offering students opportunities to engage in cutting-edge projects.Diverse and Inclusive Community:
UMBC is committed to creating a welcoming and inclusive environment for all students.Vibrant Campus Life:
Students can enjoy a wide range of activities and events on campus.Affordable Education:
UMBC offers a high-quality education at an affordable price.Academic Programs:
UMBC offers a wide range of academic programs, including:
Undergraduate Degrees:
Bachelor's degrees in various fields, including arts and humanities, social sciences, science, technology, engineering, and mathematics.Graduate Degrees:
Master's and doctoral degrees in a variety of disciplines.Professional Master's Programs:
Specialized master's programs designed for working professionals.Other:
UMBC is a member of the University System of Maryland and is accredited by the Middle States Commission on Higher Education. The university is also committed to equal opportunity and accessibility for all students.
Student Life and Campus Experience:
While the context mentions some aspects of campus life, it does not provide a detailed description of the student experience.Key Reasons to Study There:
The context highlights some advantages of studying at UMBC, but it does not provide a comprehensive list of key reasons.Academic Programs:
The context mentions the availability of undergraduate and graduate degrees, but it does not provide a detailed outline of the key academic programs and strengths of the institution.Entry Requirements:
Prerequisites:
Successful completion of the following biochemistry and molecular biology courses:
- Introduction to Biochemistry
- Molecular Biology
- Cell Biology
Other Qualifications:
- Bachelor's degree in a science or engineering field
- A minimum GPA of 3.0
- Three letters of recommendation
- A personal statement
Language Proficiency Requirements:
Non-native English speakers must demonstrate English proficiency by achieving a minimum score on one of the following standardized tests:
- TOEFL (Test of English as a Foreign Language): 80
- IELTS (International English Language Testing System): 6.5
