Faculty Syllabus

REQUIRED TEXTS AND MATERIALS

1. Textbooks: eTextBook: Jack O’Grady. “BITC1340 Quality Assurance & Regulatory Affairs for the Biosciences.” 2019. A free electronic copy is provided on Blackboard.
2. Blackboard: Students are required to utilize Blackboard for this course. The unit exercises will be made available through Blackboard only. To access Blackboard, you need an ACCeID. 

• To activate ACCeID: http://www.austincc.edu/acceid/
• To log onto Blackboard: http://acconline.austincc.edu/

1. Email: You are required to communicate with your instructors using your ACCmail account only. To obtain your email account: http://www.austincc.edu/accmail/ 
2. Technology: You are required to use a computer with a reliable internet connection, with earphones and speakers to complete your assignments. If you do not have access to this type of computer equipment at home, ACC learning lab is available for your use. 

• Are you ready? Here’s a technical skills checklist to find out: http://dl.austincc.edu/students/TechCheck.php

Assignments (500 points): 

There are ten open-book online quiz and discussion board posts that reflect each unit readings and activities. Due dates posted on the schedule. Discussion board rubric is posted here.

1. Quizzes (400 points): Each unit quiz is posted on Blackboard under “Assignments,” inside “Chapter” folders. There are 10, 40 point open book self-graded quizzes with a variety of formats, including multiple choice, true/false, matching, and short answer.
2. Discussion Board (100 points): Each unit has a 10 point discussion board prompt that relates to controversial issues around that unit topic. Students will answer a discussion board prompt/question and will also respond to a peer’s post. 

1. The original post should be well-written and address the question asked. Please research your answers, and be thoughtful and intentional in your post.

       C. Essay (50 points)

Exams (350 points):

         A.The midterm exam is 150 points, is an open book online exam taken on Blackboard. Topics will be from chapters 1-5 in the eBook. The format of this exam will be diverse and may include multiple choice, true/false, matching, short answer, and case studies.

       B. The final exam is 200 points, is an open book online exam taken on Blackboard. Topics will be from all chapters in the eBook. The format of this exam will be diverse and may include multiple choice, true/false, matching, short answer, and case studies.

Final Project (100 points): 

There is one capstone project, which has several small assignment due dates throughout the semester. See schedule for due dates. This assignment will encompass all the learning units into one comprehensive creative project applying regulatory concepts learned in this course. You may work in pairs or alone, and the format for this project is open – creativity on this project is encouraged. Instructions are posted here. 

Bonus Points (20 points): A maximum of 20 bonus points are offered throughout the semester. They may include extra assignments, field trips, and discussion board participation.

REQUIRED TEXTS AND MATERIALS

1. Textbooks: eTextBook: Jack O’Grady. “BITC1340 Quality Assurance & Regulatory Affairs for the Biosciences.” 2019. A free electronic copy is provided on Blackboard.
2. Blackboard: Students are required to utilize Blackboard for this course. The unit exercises will be made available through Blackboard only. To access Blackboard, you need an ACCeID. 

• To activate ACCeID: http://www.austincc.edu/acceid/
• To log onto Blackboard: http://acconline.austincc.edu/

1. Email: You are required to communicate with your instructors using your ACCmail account only. To obtain your email account: http://www.austincc.edu/accmail/ 
2. Technology: You are required to use a computer with a reliable internet connection, with earphones and speakers to complete your assignments. If you do not have access to this type of computer equipment at home, ACC learning lab is available for your use. 

• Are you ready? Here’s a technical skills checklist to find out: http://dl.austincc.edu/students/TechCheck.php

Chapter 1: Introduction to Biotech & Quality

Chapter 2: Introduction to Quality Principles

Chapter 3: Quality Management Systems

Chapter 4:  Food & Drug Administration

Chapter 5: Good Guidance Practices

Chapter 6:  Drugs

Chapter 7: Biologics

Chapter 8:  Medical Devices

Chapter 9:  Food & other regulated products

Chapter 10: FDA Enforcement

COURSE-LEVEL OUTCOMES

• Define biotechnology and identify biotechnology products
• Identity the importance of quality systems in bioscience companies
• Investigate comprehensive quality systems in regulated and non-regulated workplaces and understand when regulations apply.
• Describe the structure and function of the FDA and its responsibilities in regulating and monitoring regulated products such as biopharmaceuticals, biologics, & medical devices. 
• Discuss the history of regulation in the U.S. and its impact on regulatory affairs today. Identify where regulations come from in the U.S.
• Describe Good Clinical Practices (GCPs) and identify situations where they apply
• Define current Good Manufacturing Practices (cGMP), and when they are applied to manufacturing a biotech product
• Discuss the importance of Good Documentation Practices, including associated regulations and enforcement.
• Describe voluntary quality systems such as ISO9000, Lean, and Six Sigma and identify how they can be used to develop and manufacture quality products.