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Quality Science

Earlham is partnering with an independent organization called Pathway for Patient Health (PPH) to offer a minor in Quality Science that will help prepare students for careers in the life science industries– particularly in the pharmaceutical and biomedical sciences sectors. This minor includes a set of seven courses (three of these by industry experts facilitated through PPH), as well as an online portfolio website to connect students to the life science industries for paid internships and employment.

The word Quality refers to the term used in manufacturing, a measure of excellence or a state of being free from defects, deficiencies and significant variations. A Quality Scientist ensures that the product is suitable for its intended purpose. They increase the reliability, integrity, and trustworthiness of the product, process, and system by understanding failure modes and risk analysis.

The Advisory Board for this initiative at PPH includes representatives from leading life science companies such as Baxter International, Procter & Gamble, AstraZeneca and Elanco.

Our Faculty

Robert Couch
Associate Professor of Global Management

Corinne Deibel
Professor of Chemistry

Mike Deibel
Professor of Chemistry; Associate Vice President of Academic Affairs

Lindsey McGee
Assistant Professor of Biology

The Minor

The Minor in Quality Science will be most attractive to students majoring in Biochemistry, Chemistry, Biology or Neuroscience, who want to pursue employment in industry. It will be housed in the Center for Global Health and consists of seven courses totaling 23 to 24 credits.

Required Courses

    • EPIC 250 Quality Regulations in Life Science Industries (3 credits)
    • EPIC 350 Product Development, Specifications, Process and Validation (3 credits)
    • EPIC 351 Risk and Failure Analysis (2 credits)
    • MGMT 200 Financial Accounting (3 credits)

AND one of the following options

Option A

        • CHEM 111 Principles of Chemistry (4 credits – prerequisite for CHEM 431)
        • CHEM 331 Equilibrium and Analysis (5 credits – prerequisite for CHEM 431)
        • CHEM 431 Instrumental Analysis Chem 431 (4 credits)

OR

Option B

        • BIOL 112 Cells, Genes and Inheritance (4 credits – prerequisite for BIOL 461)
        • BIOL 341 Cell Physiology (4 credits – prerequisite for BIOL 461)
        • BIOL 461 Microbiology (4 credits)

Courses

Required Courses

MGMT 200 FINANCIAL ACCOUNTING (3 credits)
An introduction to the construction and interpretation of financial statements, valuation of assets, financial ratios analysis, and the construction and use of budgets for decision making.

EPIC 250 QUALITY REGULATIONS IN LIFE SCIENCE (3 credits)
This course, as part of the curriculum developed by Pathway for Patient Health, will provide students an understanding of the role of regulators with an overview of regulations as stated in the U.S. Code of Federal Regulations (CFR), EudraLex Directives and Annexes, and Emerging Market regulations for the pharmaceutical, medical device, biotech, animal health and consumer goods industries. The faculty will demonstrate the relationship between regulatory requirements and legal accountability while introducing fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control and validation. Topics such as the role of guidance documents and industry standards will be reviewed, and case studies utilized to support the program.

EPIC 350 PRODUCT DEVELOPMENT, SPECIFICATIONS, PROCESSES AND VALIDATION (3 credits)
In this course, students will be exposed to the major design processes that are critical to life science product, process and specification development. Topics to be covered include cradle to grave product and process development, prototype builds, scalability, design of experiments, variability, control, specification development and validation methodology. Instructors will explore how rigorous human factor engineering studies and clinical trials provide essential inputs into the product development process. The students will be introduced to concepts such as gap analysis, risk assessment, master plan, process characterization, installation qualification, operational qualification, measurement system analysis, repeatability and reproducibility (data collection / analysis), and performance qualification/validation. In a world of innovative technology, it is critical that the students gain an understanding of computer system and software validation to ensure the quality of data generation, data storage, and digital processes used in manufacturing and products with digital components using technical and practical aspects expected in the regulated life science industries. Prerequisite: EPIC 250.

EPIC 351 RISK AND FAILURE ANALYSIS (2 credits)
This course will dive into the nuances of the life science industries related to the specific regulations that apply to consumer health products. Through the use of historical risk analysis techniques such as FMEA, Fault Tree and 5 Why’s, students will be able to analyze a holistic set of data (in-production, across product lines, across equipment, human variability, on-market, on-stability, validation studies, change control, etc.) that will lead to scientifically justified investigations supported by evidence, and the identification of effective corrective and preventative actions (CAPA). Prerequisite: EPIC 250.

 

Option A — Chemistry

*CHEM 111 PRINCIPLES OF CHEMISTRY (4 credits)
Designed as the entry course for the major. Core principles and interesting applications of chemistry combine to provide a conceptual understanding of chemistry for professional and everyday life. Principles of atomic and molecular structure, molecular energetics and classes of chemical reactions reviewed. Aspects of gas behavior, basic photochemistry and acid-base chemistry are applied to the study of environmental chemistry issues such as stratospheric ozone, the global greenhouse effect, acid rain and photochemical smog. Lab work includes the synthesis of compounds, the study of aqueous ions, titrations, and basic IR, visible and UV spectrophotometry. Learning outcomes include a strong understanding of core chemistry concepts and skills. (A-QR)

*CHEM 331 EQUILIBRIUM AND ANALYSIS (5 credits)
Designed for chemistry majors, minors and pre-health professionals. Problem-based learning course designed to provide a working knowledge of the principles and practices of analytical chemistry. Covers two major themes: (1) the systematic treatment of chemical equilibrium in ionic systems, including acid-base, solubility, redox, and (2) methods of quantitative chemical analysis, which includes the theory and practice of volumetric analysis and modern instrumental methods of analysis (spectroscopy and chromatography techniques). Through both lecture and laboratory instruction, students will develop a theoretical foundation for a variety of methods of analytical chemistry as well as a proficiency in chemical laboratory techniques, and the ability to apply these to practical and current problems in research. The laboratory culminates in a three-week laboratory group project and a poster presentation. Learning outcomes include a strong quantitative understanding of chemical processes and instrumentation. This includes the ability to design, conduct, analyze, critically evaluate the results of, and present an analytical chemistry research project. Prerequisite: Grade of C or better in CHEM 111 or consent of the instructor. (A-QR, RCH)

CHEM 431 ADVANCED ANALYTICAL CHEMISTRY (4 credits)
The goal of this course is a systematic study of modern instrumental methods of chemical analysis with emphasis on the principles of operation of the instruments and their use for the analysis of real substances. Topics and learning goals include, but are not limited to, atomic and molecular spectroscopy, gas and liquid chromatography, mass spectrometry. Laboratory skills and learning goals include extensive hands-on experience with major analytical instrumentation: UV-Vis absorption, AAS, ICP-AES, GC and HPLC as well as important instrumentation construction skills such as data acquisition and control, electronics and the use of the machine shop. Emphasizes study of complex mixtures and the special problems of trace-level analysis. Learning outcomes include the successful understanding of the indicated goals. Prerequisites: Grade of C or better in CHEM 331. Also recommended: PHYS 230 or 235. (RCH) (AY)

 

Option B — Biology

BIOL 112 CELLS, GENES AND INHERITANCE (4 credits)
An overview of cell structure and function and the principles of inheritance, including such topics as transmission genetics, DNA structure, central dogma of molecular biology, regulation of gene expression, meiosis and mitosis, protein function, cell cycle and recombinant DNA techniques. Lab emphasizes inquiry-based experiments and contemporary techniques.

BIOL 341 CELL PHYSIOLOGY (4 credits)
An examination of basic principles of cell physiology. Topics include thermodynamics, enzyme mechanisms, photosynthesis, cellular respiration, coupling of ATP hydrolysis to cellular reactions, regulation of protein function, membrane structure, cell signaling, and neural and muscular activity. Lab emphasizes inquiry-based experiments and contemporary techniques. Prerequisites: BIOL 112 and CHEM 111 or consent of the instructor.

BIOL 461 MICROBIOLOGY (4 credits)
A study of bacteria and virusesfocusing on microbial physiology, growth, replication, genetics, ecology, pathogenesis, evolution, systematics, impact on global health, and historical and modern techniques. Research emphasizes acquiring skills in the craft of microbiology including laboratory safety, sterile technique, microbial culturing and staining, isolation and identification of unknown bacteria, antimicrobial activity and biochemical analyses. Lab. Prerequisite: BIOL 341.

Earlham College, an independent, residential college, aspires to provide the highest-quality undergraduate education in the liberal arts and sciences, shaped by the distinctive perspectives of the Religious Society of Friends (Quakers).

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