BTEC 2221 Syllabus

Subject Code

BTEC

Course Number

2221

Course Title

Regulatory Compliance in Biomanufacturing

Prerequisites

Program admission

Corequisites

Terms Offered

Offered every semester

Credit Hours

(3-0-3)

Course Description

This course explores the Food and Drug Administration (FDA) and the role of Good Manufacturing Practices (GMP) compliance in manufacturing of drugs, biologics, and medical devices. Benchmark Congressional Acts (e.g. the Food, Drug and Cosmetic Act) are studied while describing the evolution of the FDA to its present state. Students are introduced to facilities and processes used in the manufacture and packaging of drugs, biologics, and medical devices.

Course Outcomes

Evolution and activities of the FDA with regard to bioscience products
Order		Description
1		Explain the history of the development of regulatory agencies.
2		Describe major legislative acts in the development of the regulatory process.
3		Describe the organization of the Food and Drug Administration (FDA).
4		List activities of the Food and Drug Administration (FDA).
Steps required in getting a drug or biologic to the market
Order		Description
1		Describe the process of drug development from preclinical trials to marketing of a new drug.
2		Identify the requirements for an Investigational New Drug Application (IND), New Drug Application (NDA) and Biologics License Application (BLA).
3		Describe the process for meeting with the FDA.
4		Describe aspects of good clinical practices.
5		Describe the regulatory requirements for marketing of medical devices.
6		Understand post-marketing regulation.
7		Describe the role of patents in drug discovery and marketing.
Role of Good Manufacturing Practices (GMP) requirements
Order		Description
1		Describe the necessity of GMP for assuring the safety and efficacy of a biomedical product.
2		Understand relevant requirements of the Code of Federal Regulations.
3		Explain the risk-based approach to FDA regulation.
4		Understand the process of FDA inspection and warning letters.
Documentation necessary for Good Manufacturing Practices (GMP)
Order		Description
1		Understand documentation necessary to be in compliance with the FDA.
2		Define documents integral to GMP in biomanufacturing.
GMP for facilities, systems, and processes in biomanufacturing
Order		Description
1		Describe the requirements of facilities.
2		Describe plant materials.
3		Describe the operation of clean rooms.
4		Describe methods for cleaning, decontamination, and sanitation.
5		Discuss methods for sterilization of process equipment.
6		Perform receiving and quarantine operations.