QUALITY CONTROL AND VALIDATION

Name: QUALITY CONTROL AND VALIDATION
Availability: OutOfStock

ABT 735

课程描述

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.

先修课程

ABT 700 , ABT 705 , and ABT 710

满足要求

This course does not satisfy any prerequisites.

学分

未报告

开课时间

未报告

平均绩点

3.63

1.75% 相比历史数据

完成率

100%

与历史数据相比无变化

A率

37.5%

28.57% 相比历史数据

班级规模

33.33% 相比历史数据

Cumulative Grade Distribution

教师 (2026 Summr)

按评分排序，数据来自 Rate My Professors

相似课程

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.

SURVEY OF QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

BIOMDSCI 720

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.

BIOMANUFACTURING ENTREPRENEURSHIP

BME 740

Industry-relevant concepts of biotechnology innovation and translation, directly connecting lessons and classwork to real-world experience and career opportunities and promoting meaningful and sustained engagement between students and industry representatives. Diverse range of translational biotechnology principles, such as product development in biotechnology, regulating biotechnology products, and quality and compliance in biomanufactured products.

TECHNIQUES IN BIOTECHNOLOGY

ABT 715

Application of biological and chemical methods to modern biotechnological product development. Overview of analysis techniques used to characterize products and evaluate quality and safety. Exploration of technological pipeline from conception to market, including proof-of-concept assessment, pre-clinical trials, clinical trials, and post-production testing.

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.