Quality Certificate of Compliance - PDF

Document Sample
Quality Certificate of Compliance - PDF Powered By Docstoc
					       Regulatory and Quality Compliance
          Graduate Certificate Program

                                                 With emphasis on

                                              Food and Drug Law I
                                               Drug Development
                                            Good Regulatory Practice

Department of Industrial and Physical Pharmacy
Robert E. Heine Pharmacy Building, Room 124
575 Stadium Mall Drive
Purdue University
West Lafayette, IN 47907-2091
Phone: 765-494-1450
Fax: 765-494-6545
   I  Introduction

  The purpose of this certificate program is to provide                  exams will be given for each major section of the course. The
graduate level education in the important aspects of                     certificate program consists of the following courses: (1)
Regulatory and Quality Compliance in the pharmaceutical                  Food and Drug Law I, (2) Drug Development, and (3) Good
industry. In this way, students will have an opportunity to              Regulatory Practice. If taken in successive semesters (fall,
improve their knowledge of regulatory and compliance issues              spring, and summer), the program can be completed in one
and to explore careers in these exciting areas. Additionally,            calendar year.
this program provides background information on the drug                   The development of this program has been a joint
development process from discovery to the marketplace.                   effort between Purdue University, representatives from the
  This graduate certificate program consists of three courses,           pharmaceutical industry (mainly Lilly and Abbott), and
each 3 credit hours, that will be presented on weekends (about           the FDA.
one weekend per month) at the University Center of Lake                    Individuals who successfully complete the certificate
County in Grayslake, Illinois. Participants will attend classes          program may have the option to apply these 9 credit hours
12:30-5:30 p.m. Fridays, 8:00 a.m.-5:30 p.m. Saturdays and               toward or in partial fulfillment of a Master’s degree in
8:00 a.m.-12:30 p.m. Sundays. A homework assignment and                  Regulatory and Quality Compliance at Purdue.

   P    Program Objectives

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

   C    Courses
               1. Food and Drug Law I (PHAD 50100) – G. Thomas Wilson, Professor

  This course uses a legal case-based approach to aid in                   Basic Definitions & Introduction – T. Wilson
the understanding of the basic statutory and regulatory                    History of the FDA – T. Wilson
building blocks of the pharmaceutical industry, those being                Basic Concepts of Drug Law – T. Wilson
adulteration and misbranding. The goals of the course                      Adulteration, Misbranding – T. Wilson
include instilling an awareness of those events that have                  IND, NDA – T. Wilson
impacted our field and the legal remedies that have been                   Drug Recalls, Regulatory Actions – T. Wilson
adopted to deal with such catastrophes as thalidomide, elixir              Inspections – T. Wilson
sulfanilamide, the acetaminophen poisonings, and others.                   Tampering – T. Wilson
  Prerequisite: A Bachelor’s degree.                                       Orphan Drugs – T. Wilson

                  2. Drug Development (IPPH 52100) – Michael Schmidt and Stephen Byrn, Professors

  This course reviews the process of drug discovery                        Introduction – M. Schmidt
and drug development. Animal preclinical research and                      Drug Discovery – How drugs are discovered: strategies &
human clinical research are discussed in detail. In addition,                 processes – M. Schmidt & guests
the content of the IND and NDA are discussed along                         Preclinical Safety Research – Toxicology, ADME, and
with the Phases (I, II, III) of human clinical research. The                  regulatory pharmacology – M. Schmidt & guests
CMC (chemistry manufacturing and control) aspects of                       Clinical Research: Industry and Academia – The process of
drug development are also presented; ICH documents                            clinical research – M. Schmidt & guests
and manufacturing process analytical technologies. The                     CMC – CMC issues including the ICH processes
course includes a brief review of patents and proprietary                     – S. Byrn & guests
protection. Prerequisite: A Bachelor’s degree.                             Project Management, Product Decisions and Marketing
                                                                              – M. Schmidt & guests
                                                                           Patents and Intellectual Property Protection
                                                                              – S. Byrn & guests
                                                                           Conclusion – S. Byrn

                  3. Good Regulatory Practice (IPPH 52200) – Michael Schmidt and Stephen Byrn, Professors

   This course includes a review of the FDA and ICH regulations            Introduction – M. Schmidt
on good laboratory, good clinical, and good manufacturing                  Philosophy and Principles of “quality and compliance
practices. The meaning of these regulations, the globalization               management” – T. Pearson
of the practices, and the roles and responsibilities of various            GLP Module – Basis of GLPs, guidances, compliance
professionals implementing these regulations are addressed:                  – M. Schmidt & guests
pre-clincial and clinical scientists; quality control and quality          GCP Module – Basis of GCPs, guidances, compliance
assurance representatives; and regulatory affairs professionals.             – M. Schmidt & guests
Prerequisite: Drug Development (IPPH 52100).
                                                                           GMP Module – Basis of GMPs, guidances, compliance
                                                                             – S. Byrn & guests

   I    Instructors

   Dr. Stephen R. Byrn is the Charles B. Jordan Professor at the            Dr. Michael J. Schmidt graduated from the University of
School of Pharmacy, Purdue University, West Lafayette, Indiana.          Wisconsin and then received his M.S. degree in pharmacology
He received his B.A. degree from DePauw University and his Ph.           from the University of Missouri School of Pharmacy at Kansas
D. degree in Chemistry from the University of Illinois, Urbana.          City and his Ph. D. in pharmacology from Vanderbilt University
He did postdoctoral research at UCLA. His research focuses               Medical School. He did postdoctoral research at the National
on the solid-state chemistry of drugs. Dr. Byrn has extensive            Institutes of Health. He then joined Eli Lilly where he worked
experience as a consultant in the pharmaceutical industry and            first in the laboratory in brain research and then in a number
currently serves on the Council of Experts of the USP, the Drug          of management positions in the areas of discovery research,
Substance Technical Committee of PQRI, and is past chair of the          toxicology, and worldwide quality assurance for preclinical and
Pharmaceutical Sciences Advisory Committee of the FDA. Dr.               clinical studies. He retired in 2001. He has published over 50
Byrn is co-founder of SSCI, an Aptuit Company, that provides             papers and worked with numerous scientific associations. Post-
analytical chemistry services and consultation.                          retirement he consults in the pharmaceutical industry, served as a
                                                                         quality and compliance advisor to Indiana University, and served
                                                                         as a board member with several science education and youth-
                                                                         serving organization. Dr. Schmidt is founder and president of Dr.
                                                                         Bones Education Indianapolis, Inc., which is a science education
                                                                         outreach company.

    I    Instructors (continued)

  Dr. G. Thomas Wilson graduated from Purdue University                    Pharmacy in which capacity he is often called upon to draft rules
School of Pharmacy in 1975 and entered practice in pharmacy.               and statutes, many of which have been enacted. After nearly 22
He worked in independent and chain pharmacies including                    years as a member of the Administrative Professional staff, Prof.
being store manager in a small chain. He returned to Purdue                Wilson accepted a tenure track position within the School as
three years later to work and teach in the Purdue University               Associate Professor. the post he currently holds.
Pharmacy. He served 20 years as director of the experiential
programs during which time he earned his J.D. from Indiana
University School of Law, Indianapolis. He was admitted to the                Guest lecturers. Guest lecturers (experts in their field) will
Indiana Bar in 1984. Since 1986 he has had sole responsibility             be recruited by the course directors. Individuals will come
for the Jurisprudence course in the Pharmacy School. His                   from academia, industry and the FDA.
responsibilities include serving as liaison to the Indiana Board of

    A    Admission Requirements

  Students must meet the following admission requirements
for the graduate certificate and the master’s degree program:              •   Minimum overall TOEFL iBT score of 77 if English is
                                                                                not the student’s native language.
    •   Bachelors degree from an accredited institution                         See http://ipph.purdue.edu for further information
    •   Minimum undergraduate GPA of 3.0/4.0 (consideration                •   Recommendation by the department’s admission
         will be given for relevant work experience)                            committee and approval of the Graduate School

                                         You are encouraged to apply to the Graduate School by
                                               • July 1 for the fall semester
                                               • November 1 for the spring semester
                                               • April 1 for the summer semester

                      Applications must be submitted online through the Graduate School at the following URL:

    C   Completion Requirements

     • Successful completion of 9 credit hours from the three              • All courses must be completed within 5 years of beginning
        core courses                                                          the program
     • A grade of B or better must be attained for each course             • All weekends of all courses must be attended

    T    Tuition and Fees

  Individuals interested in this Certificate in Regulatory                 for by the individual student or the student’s departmental
and Quality Compliance should talk with their supervisor                   budget (with management approval). Students may also
concerning participation in the program. Tuition and fees                  be eligible for tuition reimbursement if certain conditions
for each course will be $3000. Students will be responsible                set by their employer are met. For additional information
for their housing. Breakfast and lunch will be provided.                   about tuition reimbursement, interested individuals should
Once enrolled, students will be provided with a list of                    contact their Educational Assistance Plan Administrator
hotels close to the site of the course. This cost may be paid              within their organization.

   P   Payment of Fees

  Once you are admitted to the Graduate School you will
receive information about payment and other matters.

   F   For further information contact:

Stephen R. Byrn, Ph.D.
  Charles B. Jordan Professor of Medicinal Chemistry
  Robert E. Heine Pharmacy Building, Room 308B
  575 Stadium Mall Drive
  Purdue University
  West Lafayette, IN 47907-2091
  Phone: (765) 714-2808
  Fax: (765) 494-6545

Mary Speer
 RQC Graduate Program Coordinator
 Purdue University
 3495 Kent Ave., ROSS, Suite Q
 West Lafayette, IN 47906
 Phone: (765) 494-9001
 Fax: (765) 463-4106
 E-mail: mspeer@purdue.edu

Department of Industrial and Physical Pharmacy
Robert E. Heine Pharmacy Building, Room 124
575 Stadium Mall Drive
Purdue University
West Lafayette, IN 47907-2091
Phone: 765-494-1450
Fax: 765-494-6545

Regulatory and Quality Compliance
Graduate Certificate Program
With emphasis on

Food and Drug Law I
Drug Development
Good Regulatory Practice


Shared By:
Description: Quality Certificate of Compliance document sample