Introduction

The purpose of this certificate program is to provide graduate level education in the important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. In this way, students will have an opportunity to improve their knowledge of regulatory and compliance issues and to explore careers in these exciting areas. Additionally, this program provides background information on the drug development process from discovery to the marketplace.

The development of this program has been a joint effort between Purdue University, representatives from the pharmaceutical industry (mainly Lilly and Abbott), and the FDA.

Individuals who successfully complete the certificate program will also have the option to apply these 9 credit hours to a Master's Program in Regulatory and Quality Compliance at Purdue.

This graduate certificate program consists of three courses, each 3 credit hours, that will be presented on weekends (about one weekend per month) at the Purdue University West Lafayette campus. Participants will attend classes 12:30-5:30 p.m. Fridays, 8:00 a.m.-5:30 p.m. Saturdays and 8:00 a.m.-12:30 pm Sundays. A homework assignment and exams will be given for each major section of the course. The certificate program consists of the following courses: (1) U.S. Food and Drug Law I, (2) Drug Discovery and Development, and (3) Good Regulatory (GXP) Practices. If taken in successive semesters (fall, spring, and summer), the program can be completed in one calendar year.

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 and quality control are particularly important for the pharmaceutical industry. Quality control (QC) and quality assurance (QA) groups exist in all companies. In addition, a growing number of academic institutions now have QC & QA. 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, submission of an application, and 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 the policy and regulations and core principles of their new professions, and most all have no detailed knowledge of specific skills for the job. The certificate program is aimed at providing basic education in Regulatory and Quality Compliance as related to drug discovery, development and registration.