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Pharmaceutical Sciences Online Graduate Program

College of Pharmacy

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Laboratory QA/QC

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    Description

    This course teaches the key components of quality assurance and quality control (QA/QC) and will help students to understand the need to produce sound scientific data using appropriate standards and controls, written procedures and method validation no matter what field they are employed in. This course will offer a generic description of what is required in the formation of a quality system in any laboratory. This will be achieved by describing the key principles in any QA/QC program with reference to the FDA, EPA and ISO guidelines, together with specific examples from different specializations in those particular fields.

    Because of the broad application of QA/QC in various fields, this course is intended as a foundation for everybody working or entering a quality work environment and will focus on the following areas:

    • Illustrating the general principles of workplace safety, educational requirements, and leadership responsibilities
    • Distinguishing between method validation and instrument calibration as applicable to most laboratory environments
    • Designing and executing standard operating procedures essential to consistent work operations
    • Optimizing work operations and evaluating laboratory needs to conduct specific analysis and procedures based on client needs
    • Ensuring inspections and audits are conducted and executed in a manner consistent with regulatory agency requirements.

    Course Goal

    All analytical laboratory environments are regulated by either professional organizations or regulatory bodies such as the FDA or EPA. It is therefore essential for each person working with or in such an environment to gain a basic understanding of implementation, administration, and execution of quality assurance and control procedures. Though there are specific requirements, depending on the regulatory framework set forth a few elements are common to all analytical laboratories including: method validation, article tracking, standard operating protocols and procedures, reporting, and compliance enforcement. At the end of the course, students will be able to effectively communicate core requirements with various stakeholders and apply this knowledge to recognize essential tasks and take appropriate actions to ensure quality in their work environment.

    Prerequisites

    Please review our recommended course order .


    Topics

    ModuleTopic
    Module 1Introduction to QA/QC
    Module 2Key Elements of a QA/QC Program
    Module 3Personnel and Training
    Module 4Validation of Analytical Procedures
    Module 5Equipment
    Module 6Test Article Tracking
    Module 7Standard Operating Procedures
    Module 8Study Protocols
    Module 9The Final Report
    Module 10Archiving, Archivist, Storage and Retrieval
    Module 11Specializations
    Module 12Inspection and Compliance

    Course Structure

    Group discussion forums, interactive animations, and individual e-mail contact between student and instructor. Students will be required to submit written essay assignments.

    Required Materials

    No Textbooks are required for this class.

    Library Access

    Distance Education and UF Online Students enjoy the same library privileges as on-campus students. To utilize the University of Florida Library System, click here !

    At a Glance

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    352.578.3037

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