Certificate Programs

The QA/RA program offers the following Certificate Programs:

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

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

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. 

http://www.temple.edu/pharmacy_QARA/pdf/brochure_DrugDevelopmentBrochure.pdf

http://www.temple.edu/pharmacy_QARA/pdf/app_DRUGDEVCERT.pdf

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. 

http://www.temple.edu/pharmacy_QARA/pdf/brochure_certificateinclinicaltrialmanagement.pdf

http://www.temple.edu/pharmacy_QARA/pdf/app_CLINICTRIALCERT.pdf

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, including:

Pharmacoeconomics (Pharmaceutics 5408)
Requirements for Product Labeling and Drug Information (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.

http://www.temple.edu/pharmacy_QARA/pdf/brochure_basicpharmaceuticaldevelopment.pdf

http://www.temple.edu/pharmacy_QARA/pdf/BASICPHARMDEVCERT.pdf

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:

·         Food and Drug Law I (Pharmaceutics 5592)

·         Regulation of Medical Devices: Submissions (Pharmaceutics 5502)

·         Regulation of Medical Devices: Compliance (Pharmaceutics 5496)

·         Global Medical Device Regulation (Pharmaceutics 5505)

·         One of the following pharmaceutical QA/RA electives: Quality Audit (Pharmaceutics 5494) or Computer Validation (Pharmaceutics 5498) or Process Validation (Pharmaceutics 5474) or Pharmaceutical Packaging:  Technology & Regulation (Pharmaceutics 5541)

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

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

http://www.temple.edu/pharmacy_QARA/pdf/brochure_medicaldevicecertificate.pdf

http://www.temple.edu/pharmacy_QARA/pdf/app_MEDICALDEVICECERT.pdf

 


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

 


 

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

 

7. Post-Master’s Certificates in Advanced Quality Assurance an Regulatory Affairs

New electives are frequently added to the QA/RA program to reflect the latest developments in the QA and RA arenas.  Many MS graduates want to continue taking courses to keep up with changes in the industry.  As a result, the School of Pharmacy now offers certificate programs 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 either certificate, 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 or RA.

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

http://www.temple.edu/pharmacy_QARA/pdf/brochure_Post-MastersCertificates.pdf

http://www.temple.edu/pharmacy_QARA/pdf/POSTMSCERTapp.pdf

Master’s Students from Other Schools:  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.  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.

 

8. Post-Master’s Clinical Trial Management Certificate

Students who have received the MS in QA/RA 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 additional courses beyond the MS to receive the additional certificate in CTM.
Only the following courses may be taken towards completion of this program:

*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. 

Post-Master's Clinical Trial Management Certificate Program Application

9.  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 certificate in Medical Devices.
Only the following courses may be taken towards completion of this program:

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

Post-Master’s Certificate in Medical Devices Program Application

10. Advanced Certificate in GMPs for the 21st Century

Students who have received the MS 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. 

Advanced Certificate in GMPs for the 21st Century Program Application


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

Students who have received the MS 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. 

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

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, including transcripts of courses taken in the QA/RA program. Sorry, but we cannot process your certificate without you formally applying first!  The application forms are available on the QA/RA homepage, under Brochures

2.      When you have finished your courses, you must notify the QA/RA Office by fax (267.468.8656) that you are eligible to receive the certificate.  The fax must include your name, TUid, courses completed, daytime phone number, and the certificate you have completed. 

Certificates are only processed three times a year (early February, June and September). You must notify the Graduate Studies Office of your eligibility to receive the certificate at least one month before certificates are issued, otherwise you will have to wait until the next time they are processed. 

Deadline dates:
January 31st to receive your certificate in February
May 31st to receive your certificate in June
August 31st to receive your certificate in September