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Purdue University School of Pharmacy and Pharmaceutical Sciences Department of Industrial and Physical Pharmacy. Graduate Certificate and Masters Degree Programs in… Regulatory and Quality Compliance. Educating Regulatory, Quality and Compliance Professionals.

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Purdue University School of Pharmacy and Pharmaceutical Sciences Department of Industrial and Physical Pharmacy

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Purdue university school of pharmacy and pharmaceutical sciences department of industrial and physical pharmacy

Purdue University School of Pharmacy and Pharmaceutical SciencesDepartment of Industrial and Physical Pharmacy

Graduate Certificate and Masters Degree Programs in…

Regulatory and Quality Compliance


Purdue university school of pharmacy and pharmaceutical sciences department of industrial and physical pharmacy

Educating Regulatory, Quality and Compliance Professionals


Unique features of purdue s program design

Unique Features of Purdue’s Program Design

  • Comprehensive program

  • Clearly defined criteria

  • Consistency in content and delivery

  • Student accountability


Our purpose

Our Purpose…

To grow your professional capabilities in the areas of regulatory affairs and quality and compliance practices.

To make you more insightful and perceptive, and a better problem seeker and solver.

To make you a more effective team member, and a learned mentor to others.

To prepare you to help your organization avoid costly and time consuming problems in new product development and registrations.

To develop you to grow professionally and to contribute significant value to your company.


Learning environment

Learning Environment

  • Instructors

    • University professors

    • Industry experts

  • Experience based discussion

    • Peer to peer learning

    • Instructor expertise

  • University setting


Benefits for student

Benefits for Student

  • Format compatible for working professionals

  • Focused on relevant and current content

  • Broad basic understanding across discovery, development, registration, and marketing

  • Opportunity for career acceleration and professional development

  • Graduate Certificate Degree or Masters Degree


Business benefits

Business Benefits

  • Exposure to pharmaceutical and medical device regulations

  • FDA and ex-US regulations

  • Masters’ project pertinent to business situations

  • Focuses on value of continuous improvement

  • Professional growth for employee


History of the program

History of the Program

  • Begun in 2001in the School of Industrial and Physical Pharmacy

  • Driven by independent input from Todd Chermak (Abbott) and Michael Schmidt ( Lilly, retired)

  • Established at Purdue by Steve Byrn, Department Head

  • Grown from

    • One to seven courses

    • Graduate certificate plus Masters degree


Overview of drug discovery process

Overview of Drug Discovery Process

From Nature Reviews 2:919, 2003


Drug development in a dynamic global industry

Laboratory Trials (Animal)

Healthy Volunteers

Small # of Affected Patients

Discovery

Generic Competition

Large # of Affected Patients

Regulatory Review & Approval

Marketed Drug

Drug Development in a Dynamic Global Industry


Graduate certificate degree

Graduate Certificate Degree


Graduate certificate program

GraduateCertificate Program

  • Format

    • 1 weekend per month

    • 3 weekends per course

    • 3 courses per Certificate Program

  • Note: Credit hours can be applied to the Masters Degree program


Masters degree program

Masters Degree Program


Masters degree program1

Masters Degree Program

TOTAL ELECTIVE COURSE CREDITS = 14


Masters degree

Masters Degree

  • Requirements

    • 4 Required Courses

    • 1 Special Project

      • Approved by Masters Committee

    • Elective courses

  • Total 32 Semester Credits


Masters degree special project

Masters Degree Special Project

  • Project Statement presented to Masters Committee

  • Emphasis on process/continuous improvement

  • Add value to organization…integrated into job

  • Approximately 1 year to develop and complete

  • Purdue staff available for counsel

  • End Result:

    • Written report (30-40 pages)

    • Oral presentation for approval by Masters Committee


Purdue university school of pharmacy and pharmaceutical sciences department of industrial and physical pharmacy

All Special Projects are completed and reviewed under strict confidentiality to protect company intellectual property


Program goal

Program Goal

  • To provide a meaningful educational experience in regulatory and quality compliance


Program objectives

Program Objectives

  • To Provide:

    • A broadened understanding of product development

    • An understanding of interdisciplinary relationships

    • Emphasis on strengthening problem solving skills

    • Framework to educate and mentor colleagues

    • Interaction between professionals with different experiences and backgrounds


This course meets these objectives by

This Course Meets These Objectives by:

  • Presenting and discussing relevant topics

  • Utilizing experienced professionals to teach and to answer questions

  • Assigning good reading and reference materials

  • Requiring homework that renders deep insights and new personal growth

  • Encouraging and providing time for professional interactions amongst classmates and with instructors

  • Being academically demanding…highly credible…and widely recognized


Improvement project outcomes

Improvement Project Outcomes

Some Students’ Comments

  • Value added…for sure!

  • Won my company’s “Improvement Award” prize.

  • Complex, detailed…a great learning experience.

  • Fit perfectly into my job description…nice.

  • Appreciated, and now being replicated elsewhere.

  • Got to know a lot of new people and areas as a result of doing my project. Great networking!


Personal benefit outcomes

Personal Benefit Outcomes

Some Students’ Comments

  • Got promoted!

  • Out-competed the others for the job, even though I didn’t have as much service credit.

  • Positive comments from my supervision at Performance Management Review time.

  • Moved to a new job. The program gave me insights about this new career path for me.

  • I now can understand and track the conversations in team meetings. I don’t “check-out” when toxicology starts talking!


Purdue university school of pharmacy and pharmaceutical sciences department of industrial and physical pharmacy

Now some commentary from and Q & A

with our ALUMNI…and your colleagues!


Now what

Now What…?

  • Come talk to us now

  • Grab information now

  • Follow-up via our web site at www. ipph.purdue.edu

  • Talk to your supervision.

  • Talk to the Continuing Education Department.

  • Call us at (765) 494-6545


Purdue university school of pharmacy and pharmaceutical sciences department of industrial and physical pharmacy

We would like to thank the many employees of Abbott and Lilly, and the FDA who have contributed to the success of our program.


Purdue university school of pharmacy and pharmaceutical sciences department of industrial and physical pharmacy

Purdue University

School of Pharmacy and Pharmaceutical SciencesDepartment of Industrial and Physical Pharmacy

Graduate Certificate and Masters Degree Programs in…

Regulatory and Quality Compliance

“Educating Quality and Compliance Professionals”


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