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Health Careers Education
Introduction to Biotechnology
This course serves as an orientation to the field of biotechnology. Students will become familiar with important events in the development of biotechnology, explore the applications of biotechnology in industry, agriculture, diagnostics, and medicine, and study the impact of bioethics on the field of science and their daily lives. Students will be required to research the career options available in the field of biotechnology and laboratory science, and will give an oral presentation about a specific field of study. Students will also receive experience in documentation of laboratory results, proper maintenance of a laboratory notebook, writing and following laboratory protocols, completion and use of a chain of custody, and maintenance of chemical inventory logs. In addition, students are introduced to federal regulations and regulatory agencies.
Lara Skaggs
Biology I
A. Biotechnology: Past, Present, and Future

1. Describe the science of biotechnology and identify its product domains.

2. Describe major historic developments in biotechnology fields such as pharmaceuticals, agriculture, diagnostics, industrial products, instrumentation, and research and development.

3. Identify the major scientific discoveries that lead to recombinant DNA technology, including those in chemistry, genetics, microbiology, and fermentation technology, and explain how those discoveries are used in industry today. Include role of: Mendel, Avery, Watson and Crick, Cohen and Boyer.

4. Identify examples of biotechnology products and companies.

5. Outline the steps in production and delivery of a product made through recombinant DNA technology.

6. List and explain the importance of each stage in the process of creating a new product, beginning with research and development and ending with manufacturing and sales.

7. Describe the role of federal agencies in the regulation of new product testing and clinical trials.

8. Explain how scientific methodologies are used to conduct experiments and develop products.

B. Careers in Biotechnology

1. Elaborate the opportunities for careers in biotechnology in health, medicine, genetics, agriculture, etc.

2. Present arguments for pursuing careers in biotechnology at differing entry-levels.

3. Demonstrate knowledge of the vast variety of departments and positions, scientific and nonscientific, at a typical biotechnology company.

4. Research the educational requirements of a variety of jobs in the biotechnology field.

5. Research a specific biotechnology-related job or career cluster and create a presentation that communicates this information in a professional manner.

C. Bioethics and Decision Making in the Biotechnology Industry

1. Cite specific examples of how and where biotechnology is used in medical, agricultural, environmental, and industrial applications as well as social or political situations, including criminal investigations, lawsuits, evolutionary studies, etc.

2. Illustrate examples of how biotechnology has lead to benefits and risks to society and how biotechnical advances affect human lives on a personal level.

3. Identify the rights, interests, and responsibilities of people involved in bioethical issues.

4. Describe the need for and function of regulatory agencies such as those in government, industry, and society.

5. Analyze policy-making procedures for products and techniques of biotechnology.

6. Formulate opinions about engineered organisms and products based on current scientific evidence.

7. Concerning the early ethical/safety concerns around recombinant DNA technology, describe the role of the RAC committee, the Asilomar Conference of 1975, the NIH Guidelines. Define the different levels of physical and biological containment safety measures.

D. Humans and Biotechnology

1. Define the term human genome project (HGP).

2. Discuss the estimated number of DNA and genes in the human genome.

3. Explain possible benefits from the HGP.

4. Define the ELSI group, and discuss potential concerns that could arise from the HGP.

5. Define and describe the function of bioinformatics.

6. Describe the international nature of the HGP.

7. Define and discuss the applications of human gene therapy.

8. List two genetic diseases and explain how gene therapy might be helpful.

9. Identify and discuss some of the difficulties that must be resolved before gene therapy can be successfully implemented.

10. Define DNA typing/fingerprinting and explain some of its societal/forensic uses.

11. Define and describe RFLP, VNTR, and STR then be able to look at a DNA profile diagram and determine a match in a given case study such as determination of paternity.

12. Given a piece of DNA to be amplified, be able to describe what the appropriate primers would be.

13. Identify the five ethical principles and explain the considerations in a decision-making model for bioethical issues.

14. Distinguish between the different uses of the term "clone" and explain two examples of different uses.

15. List in order and describe the steps in somatic cell nuclear transfer.

16. Compare and contract reproductive cloning and therapeutic cloning

17. Explain the importance of stem cells to biotechnology, list the types commonly used, and identify the sources of different types of stem cells.

E. Describe and Adhere to Federal Regulations

1. Describe the role of federal agencies in the regulation of new product testing and clinical trials.

2. Demonstrate the ability to locate and apply regulations from the following federal agencies: U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA),U.S. Occupational Safety and Health Administration (OSHA), the National Institutes of Health (NIH), the National Research Council (NRC), the Department of Transportation (DOT), Clinical Laboratory Improvement (CLIA 88) Amendment of 1988 Protein tech skills, the U.S. Environmental Protection Agency (EPA), the Centers for Disease Control (CDC) and Nuclear Regulatory Commission (NRC.

F.Describe and Adhere to State, Local and Industry Regulations

1. Identify the importance of state, local and industry regulations and determine their importance in maintaining the quality of laboratory testing and product manufacturing.

2. Review and adhere to Oklahoma Department of Health regulations

3. Review and adhere to Hazmat guidelines.

4. Demonstrate the ability to locate and apply industry regulations from the International Organization for Standardization (ISO) and explain how they relate to laboratory certification.

5. Adhere to Industry recognized International Organization of Standardization (ISO) 9000 and 1400.

6. Demonstrate an understanding of the importance of Good Laboratory Procedures (GLP) and Good Manufacturing Procedures (GMP) as they relate to the quality and validation of laboratory results and industry products.

7. Perform manufacturing using current Good Manufacturing Practices (cGMP).

G.Exhibit Excellent Laboratory Documentation in compliance with global regulatory guidelines.

1. Discuss the legal ramifications of poor recordkeeping and incomplete documentation.

2. Create and maintain a laboratory notebook documenting all laboratory activities, utilizing industry-recognized standards when recording laboratory procedures and correcting entries.

3. Create data tables and graphs for the purpose of collecting and analyzing data.

4. Maintain accurate chemical inventory and Quality Assurance (QA) logs.

5. Document product specifications including the documentation of inspection and verification of integrity of product, procedure and specimen.

6. Define the term batch records and explain the importance of keeping accurate batch records in a manufacturing process.

7. Demonstrate the ability to correctly review and verify the validity of sample batch records.

8. Document customer complaints.

H. Standard Operating Procedures

1. Review SOPs to identify the key components required in a laboratory protocol.

2. Explain each phase in the development and maintenance of a facility's SOP, including writing the protocol, evaluating its accuracy, and auditing it to ensure employee compliance.

3. Develop a protocol for a designated task.

4. Evaluate protocols to verify the accuracy of designated procedures.

5. Monitor and evaluate ("audit") laboratory peers to assess their accuracy in performing laboratory procedures as outlined in the facility's SOPs.

6. Receive/observe, review, record and document corrective action according to SOP or as directed.

I. Perform Proper Procedures and Documentation for Chain of Custody

1. Define the term "chain of custody."

2. Explain why chain of custody procedures is necessary.

3. Explain the legal ramifications and identify the proper procedures in maintaining valid chain of custody records for samples and data.

4. Justify the importance of establishing and maintaining correct chain of custody procedures when handling samples and data.

5. Identify the major steps in chain of custody procedures for samples and data.

6. List and describe the proper chain of custody procedures for samples and data.

7. Explain the correct procedures for using, collecting, and storing standardized records, logs, and data forms.

8. Identify the person(s) responsible for custody of samples in a model situation.

9. Distinguish between proper and improper chain of custody procedures in a model situation.
Certificate of Completion from EPA on Chain of Custody
Syllabus for BIOT 1011: Survey of Biotechnology, OCCC, 200

-National Consortium on Health Science and Technology Education
Career Majors That Sequence This Course
Career Cluster Pathway Career Major
Health Science Biotechnology Research and Development Assistant Laboratory Animal Science Technician
Health Science Biotechnology Research and Development Biological Laboratory Assistant
Health Science Biotechnology Research and Development Biological Laboratory Technician
Health Science Biotechnology Research and Development Biological Laboratory Technologist I
Health Science Biotechnology Research and Development Biological Laboratory Technologist II
Health Science Biotechnology Research and Development Laboratory Animal Science Technician
Health Science Biotechnology Research and Development Laboratory Animal Science Technologist