Quality Regulations and Standards

Survey of Quality, Regulations, and Standards for Biotechnology

What is this “course”?

This Course-in-a-Box, CB, is about teaching quality and regulatory affairs. “Quality” products in this context means products that are suitable for their intended use and are free of defects and variability. Many vital biotechnology products have a medical or food application where a poor quality product can have serious adverse consequences. Therefore, in a biotechnology company, “quality” becomes complexly interwoven with regulatory affairs, that is, the means by which governments strive to protect consumers from defective products. Instruction in quality and regulatory affairs is essential in biotechnology curricula.

It can be challenging to develop a course in quality/regulatory affairs because this is a vast and complex field with many potential topics and pathways for instruction. This is also an area that can seem dry and uninteresting to beginning students. We therefore provide in this CB not just one, but two example courses to show the decisions made by two instructors and the resources they use to teach.

In addition to the two example courses, we provide an outline that organizes the many topics included in this field.

Additionally, we provide a few more classroom and laboratory activities that are successfully used at Madison Area Technical College when introducing concepts relating to quality/regulatory affairs.

Your contributions are also welcome. If you would like to contribute a teaching resource to this CB, contact Lisa Seidman, Lseidman@madisoncollege.edu.

What is in this collection of resources?

Example On-Line Quality Course 1 (This is an entire course contributed by Austin Community College)
Example Quality Training Course 2 (This is an entire training course contributed by Salt Lake Community College)
Outline (The outline summarizes and organizes quality/regulatory affairs topics as they are presented in various courses, books, and quality literature.)
Additional Instructional Resources (A small number of additional classroom and laboratory activities to supplement the example courses from Austin and Salt Lake.)
Quality Courses and Programs (This links to quality courses and programs associated with Bio-Link programs.)
Careers in Quality Control (Bio-Link Career Site)

Online Quality Course: Austin Community College

QUALITY ASSURANCE FOR THE BIOSCIENCES

Quality Assurance for the Biosciences is designed to be a 12 week distance learning class. This course covers topics spanning quality control and Federal Drug Administration (FDA) regulations to the biotechnology, biopharmaceutical, and biomedical device industries. Theories and application of quality assurance and quality control will be presented and several different quality systems will be discussed such as cGMP, ISO9000, Six Sigma and Lean. This class will be focused on quality in the bioscience workplace and therefore will include many applied assignments, which include internet research in current regulations and discussion board participation.

Submitted by Shelley O’Grady, Austin Community College

Open Materials:

Course Description and Brief Schedule

Orientation to the Course

Complete Syllabus and schedule

Additional Materials*

Course Project

Learning Modules

Laboratory Exercises

Exams

*Please note: You must log in to the Bio-LInk site to access the additional materials.

If you do not have an account, please request a Course-in-a-Box account.
If you already have an account for another portion of this site, you still need to request a Course-in-a-Box account.
If you came from the Curriculum Clearinghouse, you still need to request an account to view the Course-in-a-Box materials.

SLCC Quality Training Course

BIOTECHNOLOGY QUALITY AND REGULATIONS TRAINING

OVERVIEW AND SCHEDULE

Submitted by Vivian Ngan-Winward, Vivian.ngan-winward@slcc.edu

Salt Lake Community College

DESCRIPTION: This is a four day training course contributed by Dr. Vivian Ngan-Winward that is intended for instructors who want to teach quality and regulations in their own schools. The course includes lectures, classroom activities, and one laboratory exercise.

Note that Dr. Ngan-Winward’s students are encouraged to take an ASQ certification exam to become a “Certified Quality Improvement Associate, CQIA.” The lectures in this course therefore include general quality topics not specific to the biotechnology industry that relate to this certification exam.

Open Materials:

Schedule

Additional Materials:*

The following materials from Dr. Ngan-Winward’s course are provided in the additional materials section:

· PowerPoint presentation

· Descriptions of class activities and accompanying activity documents

· Description of laboratory activity

· Exams and quizes

· Supplementary resource materials

*Please note: You must log in to the Bio-LInk site to access the additional materials.

If you do not have an account, please request a Course-in-a-Box account.
If you already have an account for another portion of this site, you still need to request a Course-in-a-Box account.
If you came from the Curriculum Clearinghouse, you still need to request an account to view the Course-in-a-Box materials.

Additional Instructional Resources Relating to Quality/Regulatory Affairs

Additional Instructional Resources Relating to Quality, Regulations, and Standards for Biotechnology

Here are links to additional instructional resources (classroom and laboratory activities) that are not incorporated into the courses from Salt Lake Community College and Austin Community College. These are materials used successfully at Madison Area Technical College.

Topic: REDUCING VARIABILITY

INSTRUCTIONAL RESOURCE:

Quality Control in the M&M Factory: A classroom activity in which students practice preparing frequency tables and histograms. This activity leads to a discussion of variability and quality control in a manufacturing setting.

Topic: DOCUMENTATION

INSTRUCTIONAL RESOURCE:

Be an Auditor: Finding documentation errors. Students look for errors relating to documentation in photographs and in a simulated batch record.
Understanding Standard Operating Procedures (SOPs). Students read about SOPs and practice writing their own.
Understanding Batch Records. Students study an example batch record and look up terms associated with batch records. They then write their own batch record. Students review one another's documents, simulating the document review process in a company.
Example Batch Record. Example batch record to accompany the activity "Understanding Batch Records." Submitted by Diana Drier.

Topic: OVERVIEW OF THE REGULATION OF MEDICAL PRODUCTS IN THE U.S.

INSTRUCTIONAL RESOURCES:

Accessing the Code of Federal Regulations: Classroom activity involving reading sections of the CFR and reporting back to the class. In this activity students are exposed to the Code of Federal Regulations pertaining to drug manufacture. They also consider the types of documentation associated with certain tasks.

Kelsey Case Study: Classroom activity in which students learn about Frances Kelsey and the thalidomide tragedy and imagine themselves making the decisions she did. This case study reviews the history of thalidomide and, through questions and discussion, addresses Kelsey’s decisions, ethical issues, and political/social issues relating to biomedical products.

Topic: QUALITY IN THE LABORATORY ENVIRONMENT

Using Spectrophotometry for Quality Control: Niacin. This is a laboratory activity that uses a spectrophotometric assay from the USP and provides an introduction to quality control as a laboratory function.