Regulatory
and Quality Compliance Graduate Certificate Program
With emphasis on:
• Food and Drug Law
• Drug Discovery and Development
• Good Regulatory (GXP) Practices
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.
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 classes1:00-6:00 p.m. Fridays, 8:00 a.m.-6:00 p.m. Saturdays
and 9:00 a.m.-12:00 noon 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.
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.
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. |
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