Certificate in Pharmaceutical and Medical Device Regulatory Compliance

Certificate Level: Graduate
Admission Requirements: Bachelor's degree
Certificate Type: Post-Baccalaureate
Number of Credits to Completion: 20.0
Instructional Delivery: Online
Calendar Type: Quarter
Expected Time to Completion: 1.5 year
Financial Aid Eligibility: Not aid eligible
Classification of Instructional Program (CIP) Code: 44.0503
Standard Occupational Classification (SOC) Code: 11-9111

About the Program

The certificate in Pharmaceutical and Medical Device Regulatory Compliance is a post-baccalaureate, non-degree program designed for individuals to develop and improve career-related skills in the highly regulated field of pharmaceutical and medical device manufacturing, marketing, and sales. The program combines a core of legal compliance, risk assessment, and data privacy classes with in-depth study of the industry regulators, including the Food and Drug Administration, and their approach to regulation around research, development, sales, and marketing of pharmaceuticals, biologics, and medical devices. Ideal candidates include individuals working in and around pharmaceutical, biologic, or medical device research, manufacturing, and sales, among others.

Admission Requirements

  • A completed application
  • Official transcripts from all universities or colleges and other post-secondary educational institutions (including trade schools attended)
  • Resume
  • Additional requirements for international students

This program is designed to be completed on a part-time basis and requires 20.0 credits. Students usually finish this program in 1.5 years. If a student needs to decelerate, they should not exceed 2.5 years. Students may apply for transfer in to the Master of Legal Studies program prior to completing their certificate, and apply all earned credits toward the Master of Legal Studies.

Program Requirements

LSTU 551Compliance Skills: Auditing, Investigation & Reporting4.0
LSTU 554Risk Assessment and Management4.0
Choose three from the list below:12.0
Compliance Communications
Patients and Privacy: HIPAA and Related Regulations
Legal Regulation of Pharmaceutical and Medical Device Research and Development
Legal Regulation of Pharmaceutical and Medical Device Sales and Marketing Practices
Food and Drug Law
Information Privacy Law
The Law and Strategies Surrounding Cybersecurity
European Union Data Privacy and Protection
Total Credits20.0

Sample Plan of Study

First Year (Part-Time)
FallCreditsWinterCreditsSpringCreditsSummerCredits
LSTU 5514.0LSTU 5544.0Elective4.0VACATION
 4 4 4 0
Second Year (Part-Time)
FallCreditsWinterCredits  
Elective4.0Elective4.0  
 4 4  
Total Credits 20
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