BITC1340 Quality Assurance for the Biosciences

Summer 2024

SECTION I: CLASS INFORMATION

Instructor:               Joseph Oleniczak, Adjunct Professor, Biotechnology

Office Hours:              M W 9:00-11:00 AM on Zoom, or by appointment

E-mail:                         jolenicz@austincc.edu

  Department Chair (summer):      Dr. Kissaou Tchedre

  Email:                                 kissaou.tchedre@austincc.edu

  Phone Number:               512-223-5952 (ext 35952) or 512-228-8335

  Admin Assistant:              Mr. Steven Spurlock

  Email:                               sspulock@austincc.edu

  Phone Number:               512-223-0253

COURSE DESCRIPTION

Quality assurance principles and applications. Includes quality assurance principles as they apply to biotechnology regulated and non-regulated work environments. In-depth analysis of a broad range of quality systems and regulations including GXP, ISO9000, Lean and Six Sigma as they apply to the biotechnology, biopharmaceutical, bioscience, and biomedical device industries. Skills: G Course Type: W. No Prerequisites.

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.

COURSE RATIONALE

BITC 1340, Quality Assurance for the Biosciences, is an online-only course designed to introduce the student to quality principles and regulatory affairs as they apply to the biotechnology, biopharmaceutical, and biomedical device industries. In support of Austin Community College’s Mission Statement to support skills for “life-long learning,” this course will challenge students to apply critical thinking skills to their readings, online activities, and online peer discussions. Additionally, the goal of this course is to provide students with skills to research and apply emerging regulatory information into a variety of regulated workplaces. A significant component of this course is online discussions with peers, centering on bioethics as they apply to regulations governing the biosciences industry. Although this course provides a broad regulatory overview spanning drugs, biologics, medical devices, food and other products, students are encouraged to explore more deeply areas that interest them through a creative capstone research project.

INSTRUCTIONAL METHODOLOGY

This is a distance learning, online-only, course. Students must have reliable internet access to retrieve course materials, to communicate with instructor and classmates, and to complete assigned online activities by scheduled due dates. A high-speed Internet connection and a computer with speakers will be necessary to complete assignments. This class is not self-paced, and the student must complete assignments by the due dates listed on the schedule and access Blackboard weekly to stay enrolled in the course.

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

SECTION II: GRADING SCHEME AND MISSED EXAM POLICY:

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 (300 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. Paragraph/Essay (100 points) Each unit will have a paragraph or essay worth 10 points

Exams (400 points):

1. 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.
2. 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 and discussion board participation.

SUMMARY GRADING SCHEME:

Exams                                    350 (150 midterm, 200 final)

Unit Exercises                        500 (discussion board, quiz, and essay/paragraph)

Final Project                           100

Essay                                        50                             

Total Points                            1000

Divide total points by 10 = Grade %

Grading Scale: 90 100% = A; 80 89% = B; 70 79% = C; 60 69% = D; < 60% = F

Percentage scores will be rounded to the nearest whole number.

SECTION III: ACC & CLASS POLICIES

Coursework Expectations. To be successful in this course, you must have a strong commitment to succeed. Although this is a distance learning class, it is not self-paced. Students are expected to complete weekly assigned readings, activities, and quiz assignments by the deadlines on the schedule. Students should expect to spend approximately 8-10 hours weekly, studying each chapter and completing assignments. 

Expected Response Times in Communication. EMAIL REPLIES: The majority of faculty-student communication will be via email from 8am-5pm, Monday to Friday, within 24-48 hours of receipt of the email. During the weekends or holidays, the response time may be delayed by the next business day. DISCUSSION BOARD POSTS: I will reply to at least 4 of your posts personally throughout the semester (2 in the first half, 2 in the second half), in addition to providing private personal feedback through the grade book. Also, I will provide discussion board feedback and personal grade book feedback on both capstone project posts.

Grading Expectations. All graded material will be graded and posted to Blackboard within one week after the material has been submitted. Feedback on the unit quiz and discussion board posts are provided in the grade book. If you request additional feedback, please email to schedule an appointment or come to office hours.

Netiquette. Since this is an online course, instructor and student communication will be mainly through email. It is expected that all email communication be courteous, polite, respectful, and thoughtful. Remember that email can be a difficult medium to navigate and always err on the side of positivity. Here are some general guidelines. You will be given one growth opportunity before being removed from the course.

1. Use appropriate subject heading in email – always include “BITC1340” in the heading.
2. Use an appropriate level of formality (no texting language; hey, lol, ttyl)
3.  Avoid using all capital letters (it will seem like you are shouting)
4.  Use humor carefully as it may be misinterpreted.

Attendance/Class Participation. This is a distance learning course with no in-person meetings. However, there are some time-sensitive commitments you must keep to maintain enrollment.

1. Complete the orientation assignment in the first week of class
2. Respond to the instructor’s email within 48hrs, Monday to Friday
3. Access Blackboard at least once a week to obtain and complete the assignment. You must submit assignments – to maintain enrollment.
4. You must participate in the discussion board, collaborative projects with other students in a timely fashion -to maintain enrollment.
5. Students not completing three assignments (including discussion board posts) in a row may be dropped from the course.

6.    Weekly Chapter Quizzes. There are 10, weekly quizzes this course. The assigned reading will include one chapter from the course textbook with a variety of online research activities. There is a short quiz pertaining to the assignment, in addition to discussion board participation, which must be completed by the due dates posted on the schedule. No, you do not submit your textbook exercises for grading. J All assignments must be written in your own words.

Late Assignment Policy. All assignments are due on the date posted on the schedule. Late assignments are not accepted. There is *one* unit makeup to regain partial credit for a missed or late unit quiz. Instructions are on Blackboard. To maintain enrollment, you must not miss 3 assignments in a row.

Midterm Exam & Comprehensive Final Exam. The open-book midterm and final exam will be given online on Blackboard ONLY. There are no retests; once you take an exam, you may not take it again to try for a better grade. Once you start the exam, you may not stop it or save it and continue another time. Although this is an open-book exam, there IS a time-limit. Questions will be randomized, answers will be randomized, and you will only be permitted to see one question at a time with no backtracking. The format for these exams is multiple choice, fill in the blanks, short answer, case study and analysis, ordering, and match up. You must write all answers in your own words.

Missed Exam Policy. Makeup Exams and homework are provided for emergencies only. You must contact the instructor within 24 hours past the due date. Upon instructor approval, a new deadline is set and sent to the student by email. To maintain enrollment, you must complete the midterm exam.

Withdrawal Policy: It is the responsibility of each student to ensure their name is removed from the roll should they decide to withdraw from the class. The instructor does, however, reserve the right to drop a student should they feel it is necessary. If a student decides to withdraw, they should also verify that the withdrawal is submitted before the Final Withdrawal Date. The student is also strongly encouraged to retain their copy of the withdrawal form for their records. Students who enroll for the third or subsequent time in a course taken since Fall, 2002, may be charged a higher tuition rate, for that course. State law permits students to withdraw from no more than six courses during their entire undergraduate career at Texas public colleges or universities. With certain exceptions, all course withdrawals automatically count towards this limit. Details regarding this policy can be found in the ACC college catalog.

Withdraw Dates: Are posted on the ACC academic calendar: http://www.austincc.edu/calendars/academic-calendar

Incomplete Award Policy.  An instructor might assign a grade of “I” (Incomplete) if a student was unable to complete all of the objectives for the passing grade in a course.  An incomplete grade cannot be carried beyond the established date in the following semester. The completion date is determined by the instructor but may not be later than the final deadline for withdrawal in the subsequent semester. Note, incomplete grades are rarely given in this class and will be given entirely at the instructor’s discretion.  To get an incomplete grade (“I”) in this course, you must complete the following before the last class meeting:

1. Present a valid and well-documented reason, submitted in writing, for the instructor to give an incomplete grade, which should include the reason that the student has missed the official drop deadline for that semester.
2. Complete midterm exam, 70% unit assignments, and have at least a 70% grade average in the course.
3. Meet with your instructor to discuss what is involved in getting and finishing an incomplete. Incomplete grades must be completed by approximately two weeks before the end of the next semester.  If not completed by that time, the incomplete grade becomes a failing grade (F).
4. Sign an Incomplete Grade Form, and give it to the instructor before the last day of class.

An incomplete grade is not awarded for procrastination.  An Incomplete grade must be completed by the due date in the academic calendar of the following semester. If not completed by that time, the incomplete becomes a failing grade.

Reinstatement Procedures. Reinstatement procedures will follow those outlined in the current ACC General catalog.

Scholastic Dishonesty: A student attending ACC assumes responsibility for conduct compatible with the mission of the college as an educational institution. Students have the responsibility to submit coursework that is the result of their own thought, research, or self-expression. Students must follow all instructions given by faculty or designated college representatives when taking examinations, placement assessments, tests, quizzes, and evaluations. Actions constituting scholastic dishonesty include, but are not limited to, plagiarism, cheating, fabrication, collusion, and falsifying documents. Penalties for scholastic dishonesty will depend upon the nature of the violation and may range from lowering a grade on one assignment to an “F” in the course and expulsion from the college. See the Student Standards of Conduct and Disciplinary Process and other policies at http://www.austincc.edu/handbook 

YOU MUST WRITE ALL YOUR HOMEWORK AND EXAM ANSWERS IN YOUR OWN WORDS OR RISK BEING DROPPED FROM THE COURSE.

Student Rights and Responsibilities: Students at the college have the rights accorded by the U.S. Constitution to freedom of speech, peaceful assembly, petition, and association. These rights carry with them the responsibility to accord the same rights to others in the college community and not to interfere with or disrupt the educational process. Opportunity for students to examine and question pertinent data and assumptions of a given discipline, guided by the evidence of scholarly research, is appropriate in a learning environment. This concept is accompanied by an equally demanding concept of responsibility on the part of the student. As willing partners in learning, students must comply with college rules and procedures.

Statement on Students with Disabilities: Each ACC campus offers support services for students with documented disabilities. Students with disabilities who need a classroom, academic or other accommodations must request them through the Office of Student Accessibility Services (SAS). Students are encouraged to request accommodations when they register for courses or at least three weeks before the start of the semester. Otherwise, the provision of accommodations may be delayed. Students who have received approval for accommodations from SAS for this course must provide the instructor with the ‘Notice of Approved Accommodations’ from SAS before accommodations are provided. Arrangements for academic accommodations can only be made after the instructor receives the ‘Notice of Approved Accommodations’ from the student. Students with approved accommodations are encouraged to submit the ‘Notice of Approved Accommodations’ to the instructor at the beginning of the semester because a reasonable amount of time may be needed to prepare and arrange for the accommodations. Additional information about Student Accessibility Services is available at http://www.austincc.edu/sas

ACC Policy Concerning Copyrighted Materials: Course materials provided may be copyrighted. Students currently registered for this section have permission to print one copy of course materials for their personal use. If students would like to share course material, please contact the instructor to inquire.

Campus Carry. On June 1, 2015, Texas Senate Bill 11 (SB 11) was passed by the Texas Legislature and signed into law by Governor Greg Abbott. This law is also known as “Campus Carry.” The law allows licensed gun owners to carry a concealed handgun on public college campuses. As a public community college, ACC is required by law to implement the campus carry legislation beginning August 1, 2017. Although this is an online course, you may consider using on-campus resources and should be aware of this new law. For additional information, please link to the website. http://www.austincc.edu/campus-carry

Student Support & Success Resources (Student & Instructional Services): ACC strives to provide exemplary support to its students and offers a broad variety of opportunities and services. Information on these services and support systems is available at   http://www.austincc.edu/support-and-services 

SECTION IV. ORIENTATION HOMEWORK ASSIGNMENT

1. Obtain an ACCeID and ACCmail Account: ACCeID: http://www.austincc.edu/acceid/ , ACCmail: http://www.austincc.edu/accmail/    
2. Orientation Quiz & Discussion Board: Log onto Blackboard and complete the following: https://acconline.austincc.edu/webapps/portal/frameset.jsp

Under “my courses” click on BITC1340. On the left-hand side, you will see a series of buttons. Click on each to see where they take you!

1. Post an introduction on the discussion board: Click on the tab “Discussion Board.” You will see a discussion board set up for each Chapter Assignment. Click on the “Orientation” forum. Make a post to introduce yourself to the class by pressing the “+Thread” button at the top left-hand side of the screen. Include your name with your interest in taking this class.
2. Take the orientation quiz. Click on “Assignments” tab, click on the “Orientation to BITC1340” folder and start the “Orientation and Syllabus Quiz.” You may open and save it as you complete it. You MUST remember to press “Submit” at the bottom for it to be graded.

REQUIRED TEXTS AND MATERIALS

1.     Textbooks: eTextBook: Jack O’Grady and Linnea Fletcher “BITC1340 Quality Assurance & Regulatory Affairs for the Biosciences.” 2022. 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/

BITC 1340  Schedule

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.