- Biotech degrees / certificates
- Event Materials
- Photo Gallery
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
- 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.
- 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.
- 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.