Introduction

The purpose of this part-time master's degree program is to provide graduate level education in the important aspects of regulatory and quality compliance as applied to the pharmaceutical and medical device industries. Upon completion, graduates will have acquired an in-depth knowledge and hands-on experiences in the organization and operation of the major departments of a pharmaceutical company, as well as ways of dealing with regulatory and compliance issues.

Instruction is provided by academics, consultants, or industry representatives with years of experience and who are experts in their fields.

This master's degree program consists of ten courses (each 3 credit hours) and a special project (6 credit hours). There are four required courses, two specified elective courses, four elective courses and a 6 credit hour project. The four required courses are (1) US Food and Drug Law: (2) Drug Discovery and Development; (3) Good Regulatory (GXP) Practices: and (4) Food and Drug Law II. The two specified electives must be chosen from the following list: (5) Quality Management Audits and Inspections; (6) Documents and Dialogues of Drug Development and Registration; and (7) Process Analytical Technologies. The seven courses are presented on weekends (about one weekend per month) at Purdue University, West Lafayette, Indiana. Participants attend classes 12:30 - 5:30 p.m. Fridays, 8:00 a.m. - 5:00 p.m. Saturdays and 8:00 a.m. - 12:30 p.m. Sundays. A homework assignment and exams will be given for each major section of the course. Four additional 3 credit "elective courses" will be needed and those are at the student's discretion. However, courses self-elected must be approved by the student's M.S. degree advisory committee.

Program Objectives

High quality and appropriate compliance are essential for the viability of American industry, and academia as well. Almost daily, examples come to light showing the downside of poor quality or compliance: operations or organization closed, fines levied, careers affected, public images besmirched, credibility lost. Regulatory affairs, quality, and compliance are particularly important for the pharmaceutical industry. Quality control (QC) and quality assurance (QA) groups exist in all companies to help assure effective submissions to agencies worldwide. In addition, a growing number of academic institutions now have QC & QA groups. Similarly, knowing the agencies, the regulations, the regulators, and keeping abreast of regulatory changes is vital for appropriate compliance. Regulatory affairs staff are charged with these important responsibilities during the development and submission of an application, and the marketing of a new drug or device. However, staff for QC and QA and Regulatory Affairs are most often recruited from operations areas; few have any formal education on policies and regulations and core principles of their new professions, and most have no detailed knowledge of specific skills for the job. The Purdue masters degree program is aimed at providing advanced education in regulatory and quality compliance.