BIO 455 - Validation and Regulatory Affairs

Institution:

Farmingdale State College

Subject:

Description:

An introduction is provided to governmental oversight of drugs, devices and biotherapeutics, and the laws and regulations that apply to development, testing, and validation of methods and equipment. There is a survey of the history of U.S. food and drug law, the creation of the FDA, and the current organization and responsibilities of the FDA. Specific U.S. laws and regulations applicable to drugs, devices and biologics and international regulations and import/export concerns are examined. Details of the procedures and key issues for new product submissions for drugs, devices, biologics, and combination products, and the FDA product approval process, are presented. Laboratory activities include the development of product manufacturing procedures, practice in validation documentation, exposure to the FDA inspection process, and analysis of FDA regulatory actions. Prerequisite(s): BIO 340 with a grade of C or better, IND 401 with a grade of C or better (3,0) 3 credits Contingent on demand

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

WWW.FARMINGDALE.EDU

Phone Number:

(516) 420-2000

Regional Accreditation:

Middle States Association of Colleges and Schools

Calendar System:

Semester

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