Certificate Programs

The QA/RA Graduate Program Offers the Following Certificates

Pre-Master's Certificates
Drug Development
Clinical Trial Management
Basic Pharmaceutical Development (for students with non-science backgrounds)
Medical Devices
Global Pharmacovigiliance: Benefit-Risk Assessment
GMPs for the 21st Century
Biopharmaceuticals and Generic Drugs

Post-Master's Certificates:
Advanced Quality Assurance and Regulatory Affairs
Clinical Trial Management
Medical Devices
GMPs for the 21st Century
Global Pharmacovigiliance: Benefit-Risk Assessment
Biopharmaceuticals and Generic Drug

1. Drug Development Certificate
 

To receive a letter of completion for the Drug Development Certificate, the following courses must be successfully completed (grade of B or higher) within a three-year period:

Transfer credits are not accepted towards Temple’s certificate programs. 

Drug Development Brochure

Drug Development Application

Notice of Completion

Note:  Students may obtain only one certificate before completing the MS program.


 

2. Clinical Trial Management

This 5-course certificate program is designed for pharmaceutical and healthcare professionals who are interested or already participate in all aspects of clinical trials.  It provides the tools and information needed to design, conduct and audit clinical trails of pharmaceuticals.  The courses emphasize protocol development, volunteer informed consent, study management, and the role and responsibilities of Institutional Review Boards.  Required courses include:

Transfer credits are not accepted towards Temple’s certificate programs. 

Clinical Trial Management Brochure

Clinical Trial Management Certificate Application

Notice of Completion

Note:  Students may obtain only one certificate before completing the MS program.


 

3. Basic Pharmaceutical Development (for students with non-science backgrounds)

This program is specifically designed for professionals who don’t have a science background but wish to enter the industry or enhance their knowledge of regulatory concepts and quality issues.  The core courses provide a broad background in the terminology, concepts, and regulations governing the pharmaceutical sector, while electives emphasize business practices and concepts.  The certificate requires the completion of four courses. Two are required:

Then students select two of the following QA/RA electives:

Pharmacoeconomics (Pharmaceutics 5408)
Requirements for Product Labeling and Advertising (Pharmaceutics 5533)
IND/NDA Submissions (Pharmaceutics 5495)
Food and Drug Law I (Pharmaceutics 5592)
Project Management (Pharmaceutics 5615)

Transfer credits are not accepted towards Temple’s certificate programs.

Note:  Students may obtain only one certificate before completing the MS program.

Basic Pharmaceutical Development Certificate Brochure

Basic Pharmaceutical Development Certificate Application

Notice of Completion

4. Medical Device Certificate

Increasingly, pharmaceutical companies and medical device companies are developing and marketing combination products that contain both a device and a drug component. Examples include drug coated stents, prefilled drug delivery devices and antibiotic bone cement. Companies also market medical and diagnostic devices, through device divisions or subsidiaries. Examples devices include in vitro diagnostic instruments and reagents, surgical sponges, and magnetic resonance imaging (MRI) systems. RA professionals from either the pharmaceutical industry or the medical device industry can deepen their understanding by studying the similarities and differences in pharmaceutical and medical device regulations. The Medical Device Certificate enables students to receive specific training in the medical device field, familiarizing them with its domestic and global regulations. All courses provide hands-on application of regulations and quality practices.

The certificate requires completion of five courses:

Note:  Students may obtain only one certificate before completing the MS program.

Medical Device Certificate Brochure

Medical Device Certificate Application

Notice of Completion


5. Certificate in Global Pharmacovigilance:  Benefit-Risk Assessment

The pharmaceutical industry is challenged with providing oversight of a drug’s safety throughout the product lifecycle.  This includes continually reviewing safety profiles and managing and assessing benefit and risk that arise during and after drug development.  This certificate provides a foundation in pharmacovigilance principles to both experienced professionals and those seeking entry into this career field from within and outside the pharmaceutical area.  

This five-course program provides a solid scientific and regulatory foundation in the key disciplines necessary for a successful career in the field. 

The required courses include:

Transfer credits are not accepted towards Temple’s certificate programs. 

Note:  Students may obtain only one certificate before completing the MS program.

 Global Pharmacovigilance Certificate Program Brochure

Global Pharmacovigilance Certificate Program Application

Notice of Completion

 

6. Certificate in GMPs for the 21st Century

This certificate provides a sound theoretical and hands-on approach to practices used in all of the critical stages of manufacturing, thoroughly covering the key domestic regulations of GMP systems.  The overall goals of this program is for participants to enhance their scientific understanding of the manufacturing processes, set standards for increasing product quality, improve plant efficiency, lower production costs, and meet the new compliance requirements (both domestic and global).  It challenges students to combine science with the regulatory requirements now demanded of GMPs.

The required courses include:

Transfer credits are not accepted towards Temple’s certificate programs. 

Note:  Students may obtain only one certificate before completing the MS program.

GMPs for the 21st Century Certificate Program Brochure

GMPs for the 21st Century Certificate Program Application

Notice of Completion


7. Biopharmaceuticals and Generic Drugs
This certificate focuses on the burgeoning biopharmaceutical and generic drug industry (small molecules), familiarizing students with pertinent regulations, manufacturing science, distribution practices at the local, national, and global levels. The overall goal of this program is to focus on four key areas:  the global business environment, domestic and global regulations for generic products, manufacturing science, and business distribution practices.  The courses also expose students to major trends and controversies facing the generic industry:  GIVE (Generic Initiative for Value and Efficiency), Citizen’s Petitions, and Authorized Generics. The certificate consists of five courses. Two are required: Drug Development (Pharmaceutics 5459) and Generic Drug Regulation: ANDAs (Pharmaceutics 5473). Students may choose the remaining three courses from the following accepted electives:

Transfer credits are not accepted towards Temple’s certificate programs. 

Note:  Students may obtain only one certificate before completing the MS program.

Certificate in BioPharmaceuticals and Generic Drugs Brochure

Certificate in BioPharmaceuticals and Generic Drugs Application

Notice of Completion

8. Post-Master’s Certificate in Advanced Quality Assurance and Regulatory Affairs

New electives are frequently added to the QA/RA program to reflect the latest developments in the QA and RA arenas.  Often MS in QA/RA graduates of Temple University want to continue taking courses to keep up with changes in the industry and to meet FDA regulatory requirements for training. 

Temple School of Pharmacy now offers certificates that allow students to pursue advanced coursework beyond the master’s degree and receive formal recognition for their work in either Quality Assurance or Regulatory Affairs.

To receive the Post-Master's Certificate in Advanced QA/RA, students must successfully complete four courses beyond the M.S. in QA.  Courses taken for the completion of the M.S. degree will not be counted toward Post-Master’s Certificates in Advanced QA/RA. Students must apply for the certificate before starting the courses, including a list of electives in which you are interested, so we can make sure that those classes are scheduled during the coming year.

Transfer credits are not accepted towards Temple’s certificate programs. Students may receive more than one post-master's certificate.

Brochure on Post-Master's Certficate in QA/RA

Application for Post-Master's Certificates in QA/RA

Notice of Completion

Master’s Students from Other Accredited Schools in the U.S.  Please write a letter of request to the Assistant Dean (QA/RA Program, 425 Commerce Drive, Ste 175, Fort Washington, PA 19034), indicating which courses you would like to pursue in the certificate and explaining your experience in the pharmaceutical industry.  You must include a copy of your resume and a photocopy of your final transcript from the school where you received your docotral or master's degree.  Formal permission to pursue the post MS certificate in Advanced QA or RA must be received from the Assistant Dean before the student starts any courses in the Advanced Certificate program.  The student must have sufficient industry experience and familiarity with basic QA/RA tenets to pursue an Advanced Certificate.  The completion of five approved courses is required. We suggest adding some alternates to provide yourself with greater flexibility of scheduling.

 

9. Post-Master’s Clinical Trial Management Certificate

Students who have received the MS in QA/RA from Temple University are eligible to complete the Post-Master’s Certificate in Clinical Trial Management.  Courses taken for the completion of the MS degree will not be counted towards the Post-Master’s Clinical Trial Management Certificate.  Students need to take 4 required courses beyond the MS to receive the additional certificate in CTM. Students must apply for the certificate before starting the courses.

If students have already taken one or more of the above listed courses as part of their MS program of study, they may petition to take one of the following electives as a substitute (see brochure for additional information):

*These courses only count towards the Certificate in Clinical Trial Management if the student already has an MS in QA/RA.
Transfer credits are not accepted towards Temple’s certificate programs. 

Brochure on Post-Master's Certificate in Clinical Trial Management

Application for Post-Master's Certificate in Clinical Trial Management

Notice of Completion

Master’s Students from Other Accredited Schools in the U.S. (Please refer to the Brochure on the Post-Master's Certificate in Clinical Trial Management).

10.  Post-Master’s Certificate in Medical Devices

Students who have received the MS are eligible to complete the Post-Master’s Certificate in Medical Devices.  Courses taken for the completion of the MS degree will not be counted towards the Post-Master’s Certificate in Medical Devices.  Students need to take 4 additional courses beyond the MS to receive the additional Post-Master's Certificate in Medical Devices. Three of the courses taken must be Pharmaceutics 5496, 5502, and 5505. If one (or more) of those courses were already completed while the student was pursuing the MS, the student may substitute other courses from the list of accepted courses below. Only the following courses may be taken towards completion of this program:

*These courses only count towards the Post-Master's Certificate in Medical Devices only if the student already has an MS in QA/RA from Temple University.
Transfer credits are not accepted towards Temple’s certificate programs.

Master’s Students from Other Accredited Schools in the U.S. Please refer to the Brochure on the Post-Master's Certificate in Medical Devices

Brochure on the Post-Master's Certificate in Medical Devices

Application for the Post-Master’s Certificate in Medical Devices

Notice of Completion

Master’s Students from Other Accredited Schools in the U.S.: This certificate is open to students who received their master's degree from another school; however, those students must complete "Food and Drug Law" (Pharmaceutics 5592) before taking any of the medical device courses; thus, their certificate will consist of five courses.

11. Advanced Certificate in GMPs for the 21st Century

Students who have received the MS in QA/RA from Temple University are eligible to complete the Post-Master’s Certificate in GMPs for the 21st Century.  Courses taken for the completion of the MS degree will not be counted towards the Post-Master’s Certificate in GMPs for the 21st Century.  Students need to take five additional courses beyond the MS to receive the additional certificate in GMPs for the 21st Century.
Only the following courses may be taken towards completion of this program:

*This course only counts toward the Certificate in GMPs for the 21st Century only if the student already has an MS in QA/RA.
Transfer credits are not accepted towards Temple’s certificate programs. 

Master’s Students from Other Accredited Schools in the U.S.: This certificate is open to students who received their master's degree from another school. Please see the Brochure on the Post-Master's Certificate in GMPs for the 21st Century.

Brochure on the Post-Master's Certificate in GMPs for the 21st Century

Application for the Post-Master's Certificate in GMPs for the 21st Century

Notice of Completion


12.  Post-Master’s Certificate in Global Pharmacovigilance: Benefit-Risk Assessment

Students who have received the MS in QA/RA from Temple University are eligible to complete the Post-Master’s Certificate in Global Pharmacovigilance:  Benefit-Risk Assessment.  Courses taken for the completion of the MS degree will not be counted towards the Post-Master’s Certificate in Global Pharmacovigilance:  Benefit-Risk Assessment .  Students need to take five additional courses beyond the MS to receive the additional certificate in Global Pharmacovigilance:  Benefit-Risk Assessment.
Only the following courses may be taken towards completion of this program:

Transfer credits are not accepted towards Temple’s certificate programs. 

Brochure on the Post-Master's Certificate in Global Pharmacovigilance: Benefit-Risk Management

Application for the Post-Master’s Certificate in Global Pharmacovigilance: Benefit-Risk Assessment

Notice of Completion

Master's Degree Students from Another Accredited School in the U.S.: This certificate is open to students who received their master's degree from another school. Students must take five courses.


13. Post-Master’s Certificate in Biopharmaceuticals and Generic Drugs

Students who have received the MS in QA/RA from Temple University are eligible to complete the Post-Master’s Certificate in Biopharmaceuticals and Generic Drugs.  Courses taken for the completion of the MS degree will not be counted towards the Post-Master’s Certificate in Biopharmaceuticals and Generic Drugs.  Students need to take 4 additional courses beyond the MS to receive the additional certificate in Biopharmaceuticals and Generic Drugs. One of the courses must be Generic Drug Regulation: ANDAs (Pharmaceutics 5483), unless the student has already taken that course while completing the MS in QA/RA. Then the student may substitute another course.
Only the following courses may be taken towards completion of this program:

Transfer credits are not accepted towards Temple’s certificate programs.

Master’s Students from Other Accredited Schools in the U.S. Please refer to the brochure on the Post-Master's Certificate in Biopharmaceuticals and Generic Drugs.

Brochure on the Post-Master's Certificate in Biopharmaceuticals and Generic Drugs

Application for the Post-Master's Certificate in Biopharmaceuticals and Generic Drugs

Notice of Completion

Master's Degree Students from Another Accredited School in the U.S.: This certificate is open to students who received their master's degree from another school; however, they must start with the program with Drug Development (Pharmaceutics 5459). Thus, they must complete five courses to receive the Post-Master's Certificate in Biopharmaceuticals and Generic Drugs.

How to Obtain Your Certificate when you've completed the courses

You must follow two steps to obtain your certificate:

1. You must submit a formal application for the certificate you are completing.  That consists of submitting the official Application Form to the QA/RA Office and including photocopies of your undergraduate and graduate transcripts AND a Banner transcript of courses taken in the QA/RA program.

2. When you have finished your courses, you must fax the Notice of Completion to 267.468.8565 by the stipulated deadline (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you willl have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.