LESN Online > Certificate in Regulatory Affairs

Course Descriptions (four courses required for certificate completion)

Chemistry 425 (3 credits)/CH-OL425 (professional continuing education)
Pharmaceutical Regulatory Affairs I – Discovery to Approval

This course covers the stages of the drug approval process and how these relate to the laboratory activities that provide the scientific basis for the New Drug Application (NDA). Lectures treat drug discovery, chemical process development of the active pharmaceutical ingredient (API), and pharmaceutical process development of the drug product. Regulatory issues in screening and testing, the management of the preclinical trials, and the management of clinical trials will be covered. The regulatory requirements for the production of the drug substance (API) from bench to pilot plant to full-scale manufacturing will also be covered. Included in the discussions will be Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). The regulatory issues concerning the use of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) are also covered as well as the processes for approvals of diagnostics and devices. All topics are presented by practicing professions in the regulatory affairs area.

Chemistry 428 (3 credits)/CH-OL 428 (professional continuing education)
Pharmaceutical Regulatory Affairs II – Medical Devices and Combination Technologies: Concept to Commercialization (3)

Technological advancement in the medical and veterinary fields has fueled research and development of medical devices and products resulting from combination technologies. Each year, more than 4,000 devices are reviewed by the U.S. Food & Drug Administration for efficacy and safety before being allowed to enter the marketplace. This course reviews the history of medical device law and regulations in the U.S. It also defines current requirements of science needed to allow technologies to be developed according to regulations. Case studies are used to educate students on Design Controls, Quality System Regulations, Manufacturing Requirements and International Harmonization. Specific content includes nucleic acid diagnostics, cardiovascular stents, drug delivery, cancer diagnostics, and consumer self-testing. Class presentations are used to address current issues within the field.

Chemistry 442 (3 credits)/CH-OL 442 (professional continuing education)
Pharmaceutical Regulatory Affairs III: Validation of Analytical Assays (3)

This course will cover topics such as Introduction to Analytical Terms and Concepts, Regulations for Pharmaceutical Analytical Laboratories (both Food and Drug Administration and the International Conference on Harmonization), Setting and Evaluating Instrument Performance Criteria, Instrument Acceptance, and Assay Design and Validation. Specific examples for assay design and validation, especially for HPLC are given. (Prerequisite: students should possess a background in principles of analytical chemistry plus one semester of organic chemistry or permission of the instructor)

Chemistry 463 (3 credits)/CH-OL 463 (professional continuing education)

Pharmaceutical Regulatory Affairs IV:: Commercial Production, Validation, and Process Qualification (3)
The University’s Certificate Program in Pharmaceutical Affairs has prepared students to understand applicable regulations for the discovery, development and analysis of pharmaceuticals and medical devices. This course will address the last portion of successful commercialization. The focus of the course will be the review and application of regulations and strategies related to the manufacture of pharmaceutical and combination medical device products. Underlying regulations and principles will be followed by examples and problem solving. Students will cover the following topics from the text. Additionally they will use knowledge gained from lectures to trouble shoot problems from hypothetical situations confronted by a team trying to manufacture and scale up a new product. Lecture topics from the text will include:

1. Introduction: Status and Applicability of US Regulations/EU Guidelines—General Quality Issues.
2. Personnel, Organization, and Training
3. Premises/Buildings and Facilities
4. Contamination and Contamination Control
5. Equipment
6. Materials Control
7. Production and Process Controls
8. Packaging and Labeling Control
9. Holding and Distribution
10. Laboratory Control
11. Records and Reports
12. Returned and Salvaged Drug Products
13. Sterile Products Manufacture—Basic Principles
14. GMP and Quality Assurance in Sterile Products Manufacture
15. Validation—General Principles
16. Validation---Applications
17. Self-Inspection and Quality Audit
18. US cGMPs and EC GMP Guide --- Concluding Comparison

Chemistry 477 (3 credits)/CH-OL 477 (professional continuing education)
Introduction to Pharmaceutics (3)