Frederick Community College

Course Syllabus

BPM 102, Bioprocessing Environment (3719)

Spring 2012

 

 

Class Begins:

January 30, 2011

Class Ends:

May 18, 2011

Last Day to Withdraw:

April 16, 2011

 

Instructor Information

Instructor:   Keri-Beth Pettengill

Office:   C-109

E-mail: kpettengill@frederick.edu

Phone Number: 301-846-2564

Office Hours: M 9:00 – 10:00 (online), M 10:30 am – 12:30 pm, T 10:30 am-12:30 pm*

*In the event of potential scheduling conflicts during the semester, any changes to the office hours schedule will be posted on BlackBoard.

Campus Mail Box Number: 292

 

Course Information

Course: NET

Credits: 3

Prerequisites:  EN 50A and EN 52 or ESL 95 and ESL 99

Co-requisites: None

 

Course Description:

Presents the tenets of Current Good Manufacturing Practices (cGMPs) and regulations relevant to the bioprocess manufacturing industry.  Importance of inspections and monitoring are discussed. Work-related issues are introduced, such as workplace conduct, employer expectations, company organization and policy, personal safety, and industrial hygiene.  May include one or more MANDATORY field trips, and/or guest lecturers.

 

Core Learning Outcomes:

By the completion of the course students will:

1.      Explain monitoring for safety and regulatory compliance.

2.      Examine the inspection process at a bioprocess manufacturing facility.

3.      Provide examples of good and bad workplace conduct.

4.      Demonstrate expected job expectations, including personal safety and hygiene.

5.      Apply cGMPs in a laboratory setting.

6.      Distinguish relevant regulations (e.g., 21 & 29 CFR, OSHAct, etc.) in a laboratory setting.

7.      Apply critical thinking to laboratory analysis and lecture assignments.

8.      Display life-long learning strategies.

 

Instructional Method:

Lecture material may be supplemented with current issues, slides, videos, internet web sites, hands-on activities, field trips, small and large discussion groups, literature research, and student presentations.

 

Texts for Course:

 

Lindberg, Steven E., Expediting Drug and Biologics Development: A Strategic Approach, 3rd Edition, Parexel Publishing, ISBN 978-1-882615-76-6

 

Seidman & Moore, Basic Laboratory Methods for Biotechnology, 2nd Edition, Pearson, ISBN 978-0-321-57014-7

 

Assigned Readings, TBA

Progress Report

Students will receive some form of written assessment of their progress in the course no later than the sixth week of a fifteen week semester or one-third of the instructional time for shorter sessions.

Assessment Method

Tests / Papers / Projects

Point or Percentage Value

Final Grade Scale

EXAM 1

20%

See Evaluation Method below.

EXAM 2

20%

FINAL EXAM

20%

Assignments/Quizzes

20%

Discussion Board

20%

                      TOTAL

100%

 

 

Evaluation Method

 

Final course grades are rounded to the nearest 1/100th and based on a standard percent grade scale:

 

90-100       - A

80-89.99    - B

70-79.99    - C

60-69.99    - D

Below 60    - F

 

Evaluation of this course will consist of exams, discussion board posts, quizzes, assignments and/or student projects.  Assignments, course information and any review materials will be announced in class and/or posted on the companion Blackboard site, at the instructor’s discretion. 

 

Late assignments will not be accepted. Quizzes or make-up exams will not be administered.  The final exam will be cumulative.

 

As a student enrolled in this course, it is your responsibility to ensure that you are prepared for lecture topics, and are aware of important dates, assignments, exams, guest lectures and/or field trips.  It is not the instructor’s responsibility to remind you.

 

 

Codes of Academic Integrity and Student Conduct

Students are required to uphold the Code of Academic Integrity and the Code of Student Conduct. Students who violate either of these codes may receive a failing grade in the class.  Information about these codes and other student policies, procedures, and penalties is available on the Student Policy and Procedures web page at http://www.frederick.edu/student_services/studentpolicies.aspx .

 

Student Services

A variety of services are available to assist students in succeeding at FCC. Students can learn more about these services by visiting the Student Services web page: http://www.frederick.edu/student_services/index.aspx

 

Students with disabilities who are in need of accommodations or who have questions related to disabilities services should contact the Services for Students with Disabilities (SSD) office at 301-846-2408. Students can learn more about these services by visiting the Services for Students with Disabilities web page: http://www.frederick.edu/student_services/disability.aspx .

 

Participation Policy

Students are expected to arrive on time (when required), to be prepared for, and to participate fully in all course-related activities. Being prepared includes completing reading assignments as assigned, and completing discussion board posts when assigned.  Once a weekly post has been graded, you cannot submit to the discussion thread for points. Students are also expected to be the authors of their own work, and will cite, when applicable, all work that was not created by them.

 

In the case of any instance where on-campus participation is required, if a class must be missed due to serious illness, emergency, religious holidays, or participation in official college functions the student must inform the instructor in advance in person or by email. In case of an unavoidable absence the student remains responsible for the material missed, for being prepared for subsequent classes, and for completing all assignments and other requirements of the course.

 

Assignments, discussion board posts, activities, presentations, and exams cannot be made up for points.  Failure to follow these procedures may result in a grade of zero for the exam or assignment. Papers and other assignments are due on the dates specified, and will not be accepted late. In special circumstances, the instructor may grant a one-time exception to this policy if notified by the student before the deadline for the assignment. If a student misses a lab, they may not make up that lab for inclusion in their laboratory portfolio.

 

Students are expected to act in a professional and respectful manner when posting to online discussions.  Any student who is behaving in a disruptive or disrespectful manner to other students or to the instructor will have their post removed, will receive a grade of zero for that post, and may be referred to the department chair or to applicable departments for administrative action.

 

Any student caught cheating on an exam in the Testing Center will receive a zero for that exam, and will be referred to the department chair (and other applicable academic departments) for further administrative action. 

 

Email Communication

All students will receive and be expected to use their FCC email address for their correspondence with faculty and staff at the college.  Students can establish and access their FCC email accounts at the login page: https://myfcc.frederick.edu.

 

Topical Outline

Every effort will be made to keep to this schedule; however, the instructor reserves the right to alter or amend it as necessary. Additional dates, as published in the academic schedule of classes and listed below, may be required as make-up days for inclement weather.

 

 

BPM 102 TENTATIVE Topical Course Outline

 

Class Week

 

Lecture Topic

Required Reading

The Last Day to Withdraw from this Course is April 16, 2011.

In the event of inclement weather, students are expected to complete all lecture readings and assignments out-of-class.  If inclement weather occurs during the testing period, the testing dates will be extended by one day, unless otherwise posted by the instructor.  It is the student’s responsibility to ensure they check BlackBoard for updates and revisions to the topical outline during the entire duration of the course, regardless of inclement weather.

January 30

Course Introduction

www.fda.gov

Online assignment

February 6

Biotechnology and the Workplace

Lecture 1

Chapter 1 (Seidman & Moore)

February 13

Typical Bioprocessing Company Organization, Project Management

Lecture 2

Chapter 2 (Lindberg)

Chapter 3 (Seidman & Moore)

www.fda.gov

February 20

Role of FDA in Pharmaceutical Development, Phases of Development

Lecture 3

Chapters 5, 7 (Lindberg)

Unit II (pp 46-47) Seidman & Moore

www.fda.gov

February 27

EXAM 1 in Testing Center (February 28-March 5, 2011)

March 6

Documentation (SOPs, Investigator’s Brochure)

Lectures 4, 5

Chapter 5 (Seidman & Moore)

Chapter 12 (Lindberg)

March 13

Good Laboratory Practices (GLP)

Lecture introduction and GLP (from Lectures GxP: 6-8)

Chapter 4 (Lindberg)

Unit II (pp 46-47) Seidman & Moore

www.fda.gov

March 19-25

Spring Break

March 27

Good Clinical Practices (GCP)

Lecture GCP (from Lectures GxP: 6-8), pp 37-38 (Seidman & Moore), Chapter 13 (Lindberg), www.fda.gov

April 3

Good Management Practices (GMP)

Lecture GMP (from Lectures GxP: 6-8), Chapters 6-7 (Seidman & Moore)

www.fda.gov

April 10

EXAM 2 in Testing Center (April 11-17, 2011)

April 17

Product Quality

 

Lecture 9

Review Chapters 5-7 (Seidman & Moore)

April 24

FDA Inspection Process & Monitoring

Accident Investigations, Lock out/tag out procedures; Overview of Environmental Regulations

Lecture 10

Chapters 20, 22, 28 (Lindberg)

 

May 1

Role of Safety in the Workplace: OSHA, Occupational Hazards, 29 CFR 1904 & 1910: Recording & Reporting Workplace Injuries/Illnesses, Promoting Safe Practices,

Lecture 11, 12

Unit VIII (Seidman & Moore)

Chapters 24, 30 (Lindberg)

www.fda.gov

www.osha.gov

May 8

Cumulative Final Exam (May 8-14, 2012)

May 14-18

Final Activity

May 21-22

Inclement Weather Make-Up Dates

 

The outline presented above is a plan for the semester.  Specific topics and assignments are subject to change at the instructor’s discretion.  Test dates will not change unless weather or other events prevent class from meeting, as scheduled.