Graduate Certificate: Advanced Regulatory Affairs and Quality Assurance

SCHOOL OF PHARMACY

About the Certificate

The post-master's certificate in Advanced Regulatory Affairs and Quality Assurance is designed to allow individuals holding a master's degree in Regulatory Affairs and Quality Assurance (RAQA) to pursue advanced coursework from a broad array of topics and receive formal recognition for their work. The certificate program is also open to those holding an advanced degree in the sciences who have worked extensively in the pharmaceutical industry and seek a cadre of advanced courses in RA or QA to be compliant with Food and Drug Administration regulations on training records.

Time Limit for Certificate Completion: 3 years

Campus Location: Fort Washington

Full-Time/Part-Time Status: The post-master's certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.

Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.

Admission Requirements and Deadlines

Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.

Master's Degree in Discipline/Related Discipline: Applicants completing the program to earn a post-master's certificate must hold a master's degree in Regulatory Affairs and Quality Assurance from Temple University or a peer institution. An advanced degree in the sciences is also accepted.

Applicants who did not earn their master's degree from Temple University's School of Pharmacy must formally apply to the certificate program. They must provide proof of their advanced degree, including a transcript and documentation of the titles and descriptions of previous RA/QA courses taken. A summary of their industry experience in the form of a CV or resume is also required.

Bachelor's Degree in Discipline/Related Discipline: Applicants completing the program to earn a graduate certificate must hold a B.S. degree in Biochemistry, Biology, Chemistry, Physics, or a health-related discipline.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 12-15, depending on the institution from which and/or the subject in which the master's degree was earned1

Required Courses:

Select four or five from the following approved courses:12-15
Development of Sterile Products
Pharmaceutical Biotechnology
Introduction to Toxicology
Advanced Pharmacogenomics
Special Topics in Regulatory Affairs and Quality Assurance
Fundamentals of Pharmacology and Pharmacokinetics
Pharmacoeconomics
Statistical Quality Control
Global Biopharmaceutical Industry
Pharmaceutical Laboratory Quality Systems and Operations
Biotechnology: Bioprocess Basics
Pharmaceutical Marketing
Generic Drug Regulation (ANDAs)
Process Validation
Good Laboratory Practices
Good Manufacturing Practices
High Purity Water Systems
Advanced Good Manufacturing Practices - Defining "c"
Pre-Approval Inspections
Production of Sterile Parenterals
Sterilization Processes
Quality Audit
Investigational New Drug/New Drug Application Submissions
Regulation of Medical Devices: Compliance
Statistics for Clinical Trials
Computerized System Validation
Drug Dosage Forms
Regulation of Medical Devices: Submissions
Global Regulation of Medical Devices
Environmental Law and Regulation (EPA)
Good Pharmacovigilance Operations
Advanced Audit Workshop of Quality Systems
Microbiological Concepts in Pharmaceutical Manufacturing
Active Pharmaceutical Ingredients (APIs)
Biologics/Biosimilars: A Regulatory Overview
Cleaning Validation
Global Labeling Regulation: Principles and Practices
Requirements for Product Labeling and Advertising
Regulatory Aspects of Biomedical/Technical Communication
Advanced Topics in Labeling Development
Good Clinical Practices
Clinical Trial Management
Clinical Drug Safety and Pharmacovigilance
Global Clinical Drug Development
Pharmaceutical Packaging: Technology and Regulation
Good Distribution Practices
Regulatory Intelligence
Post Approval Changes (PAC)
Global Pharmaceutical Excipient Regulation
Project Management for Clinical Trials
Post-Marketing Safety Surveillance
Vaccines: Regulatory Affairs and Quality Assurance Issues
Pharmacoepidemiology
Pharmaceutical Quality Management Systems
Regulatory Sciences: Managing the Guidelines to Quality
Global CMC Issues and Regulatory Dossier
Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics
Benefit Risk Management and Safety Signaling of Healthcare Products
Regulatory and Legal Basis of Pharmacovigilance
Global Regulatory Affairs
Regulation of Dietary Supplements and Functional Foods
Food Law
Food Labeling and Regulatory Affairs
Clinical Aspects of Pharmaceutical Medicine
Industry Interactions with FDA/Health Authorities
Clinical Aspects of Pharmaceutical Medicine II
Advanced Topics in Food and Drug Law
Regulation of Advertising and Promotions
Bioethics for Pharmaceutical Professionals
Project Management for Pharmaceutical Professionals
Clinical Data Management (CDM)
Unit Operations
Process Analytical Technology (PAT)
Statistical Design of Experiments (DOE)
Process Monitoring
Analytical Chemistry in Pharmaceutical Laboratories
Pharmaceutical Analysis
Pharmaceutical Manufacturing I: Preformulation/Formulation
Pharmaceutical Manufacturing II: Solid Dosage Forms
Physical Pharmacy I
Applied Biopharmaceutics
Total Credit Hours12-15

GPA Required to be Awarded the Certificate: 3.0 minimum

Contacts

Certificate Program Web Address:

https://www.temple.edu/pharmacy_qara/certificates.htm

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

267-468-8560

Mailing Address for Application Materials:

Temple University

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

Department Contacts:

Admissions:

Wendy Lebing, MALD, M.S.

Program Coordinator

qara@temple.edu

267-468-8560