470336 - Industrial Biotechnology and Regulatory Compliance Overview
Course Description
Industrial biotechnology produces numerous biologically-derived products and technologies that dramatically improve and sustain the diverse life on this planet. The industry is continuously and rapidly growing, offering many exciting and high-demand bioscience career paths for students. This lesson series includes eight asynchronous video lessons designed to provide students with an in-depth look at the field of biotechnology, the drug development process, the regulatory guidelines involved in drug development, testing, and product manufacture, and the key departments that ensure these processes occur properly. The lessons will not only cover biotechnology objectives found within bioscience curricula, but will also help prepare students for relevant, meaningful, high-growth careers in (bio)pharmaceutical industries and other bioscience fields.
This lesson series is appropriate for high school and post-secondary bioscience students.
Course Fee
$450 per academic year
Duration
Participants retain access to the course content and materials through the end of the academic year (June 30).
Course Access
To access your course after enrollment, please click the link below.
Click the blue “Log in to Continuing Education” button and enter your login credentials (be sure to use the same third-party credentials you entered during enrollment). You should then see your course on the UF e-Learning dashboard or by clicking Courses>All Courses.
Please note, it is common practice to enroll in multiple courses or sections in order to access all online content relevant to your program. However, you will only create one UF account once (during your first enrollment).
Contact Us
If you have questions or need assistance, please contact Stephanie DeMarco
Phone: 386.518.2118
Email: demarcos@cerhb.ufl.edu
Course Outline
Lesson 1: Introduction to Biotechnology
Biotechnology is a broad field in which products or services are developed, manufactured, and tested utilizing
biological systems. Our society has benefited in countless ways from biotechnological improvements and
advancements in sectors such as Agricultural, Healthcare, and Industrial. This lesson will provide a historical
overview of the word as well as important milestones in the field.
Lesson 2: Drug Development Overview
For any drug, drug product, (bio)pharmaceutical or medical device to be approved by the FDA, it must follow a
stepwise development process compliant with a multitude of federal regulations. In this lesson, students will be
introduced to this regulatory process, the roles of the FDA, and the historical events that led to these regulations.
Lesson 3: Current Good Laboratory Practices (CGLP) and Preclinical Trials
Current Good Laboratory Practices (CGLP) are federal regulations set in place to ensure investigational new drugs
are safe before testing in humans. They are required when conducting preclinical studies to collect data for FDA
review and approval, before continued studies in Phase I clinical trials. This lesson will cover fundamental CGLP
concepts and its importance within a regulated laboratory environment.
Lesson 4: Current Good Clinical Practices (CGCP) and Clinical Trials
Current Good Clinical Practices (CGCP) are federal regulations enforced by the FDA during clinical trials in humans. This
lesson will familiarize students with the history, purpose, phases, and basic principles of Current Good Clinical Practices.
Lesson 5: Good Manufacturing Practices
Current Good Manufacturing Practices (CGMP) are federal regulations followed by drug manufacturing companies
to ensure their products are safe and effective for humans. In this lesson, students will learn the core precepts of
the regulatory guidelines required for companies that manufacture drugs, drug products, and medical devices.
Lesson 6: Product Specifications
Manufacturers must demonstrate that all products meet specifications for safety, purity, potency, quality, identity,
and efficacy before FDA approval. This lesson will identify and describe the product attributes, how they are
connected to the final product specifications, and how these specifications are set and tested.
Lesson 7: Industry Documentation, Good Documentation Practices, and Data Capture
Good Documentation Practices (GDP) are regulatory guidelines that help drug manufacturing companies maintain a
system of controlled documents. GDPs ensure proper recording, reporting, and archiving of everything involved in
the manufacturing process. Students will learn the basic standards of GDP as well as the role of documentation in
interdepartmental communication and the lifecycle of a drug product.
Lesson 8: Company Organization and Departmental Roles in the Bioscience Industry
The industry is divided into key departments essential to ensuring all products are of high quality, are properly tested
to confirm they meet specifications, and are created in compliance with federal regulations. This lesson will outline
the different departmental roles found within a (bio)pharmaceutical company, how each department communicates
and depends on the others for success, and the opportunities for meaningful, high-growth careers.