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SURVEY OF QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

BIOMDSCI 720
과목 설명

Success in the biotechnology industry is based on learning the language and understanding the development process utilized in bringing products to market. Focus on techniques used in the biotechnology industry to comply with the quality and regulatory requirements set forth by professional and governmental agencies in the effort to develop, manufacture, and commercialize products safely for the public.

선수과목

Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology

충족 요건

This course does not satisfy any prerequisites.

학점

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개설 시기

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평점
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변화 계산 불가

수료율
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변화 계산 불가

A 비율
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변화 계산 불가

학급 규모
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과거 데이터 대비 변화 없음

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강사 (2026 Summr)

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유사 과목

LEADERSHIP IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

BIOMDSCI 722

Leaders in the Quality Assurance and Regulatory Affairs departments influence and facilitate bringing products to market within the biotechnology industry. Focus on building communication among cross functional teams; exercising writing to specific audiences; and meeting internal and external customer needs and expectations. Explore and apply how quality and regulatory affairs skills are managed within diverse product and project teams.

BIOTECHNOLOGY REGULATION AND ETHICS

BIOMDSCI 801

Explore political, legal, and ethical issues and paradigms that drive product development within the biotechnology industry with special emphasis given to how new drugs, devices, and biologics are regulated by local, national, and global agencies. Describe the regulations and ethics of human subjects' research. Develop skills to support how regulation and politics interact with business and finance to influence the formation and growth of biotechnology companies. Discuss how ethics and regulatory policy influence how biotechnology products come to market.

QUALITY CONTROL AND VALIDATION

ABT 735

Focuses on the importance of quality control and validation in biotechnology product design, development, and manufacturing. Explores quality systems and documentation, global quality standards, and methods for assessing validation including installation, operational, and performance qualifications. Overviews biomanufacturing processes, automation, and ccGMP practices necessary to meet quality standards.

TOPICS IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

BIOMDSCI 721

Quality Assurance and Regulatory Affairs departments influence and facilitate successful product development within the biotechnology industry. Use a case study approach to explore and apply how quality assurance and regulatory compliance systems are used to bring medical devices to market. Practice how cross functional teams work together to meet regulatory standards of safety.

REGULATORY PRACTICE AND COMPLIANCE

ABT 740

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.