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Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy


Validation Science Certificate

Validation is a critical and all-encompassing tool in the pharmaceutical, medical device, biotechnology and related regulated industries.  At the heart of Quality Assurance practices, validation includes every test and scientific methodology used to demonstrate that facilities, utilities, equipment, processes, computers and products meet agreed-upon standards. Validation relies on the measured precision of scientific methods.

The Validation Science Certificate will encompass a critical analysis of the validation field. Upon successfully completing the required courses, students will be able to understand and apply

This five-course (15 credit) certificate is designed professionals working in regulated industry who need theoretical, practical, and hands-on knowledge of various validation principles. After completing two required courses, participants may select three specialized electives in Validation Science that best meet their career needs.  

The two required courses are:

Elective courses include (three must be completed)

Students pursuing the Validation Science Certificate are expected to have a knowledge of cGMPs.  Students without such knowledge should consider taking Good Manufacturing Practices (5477) before starting the program.   

Students should take Process Validation (5474) before any other certificate course.  Those with prior educational or professional experience in validation science may begin the program by taking an elective course first, though the required courses must be completed to earn the certificate.

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

Brochure - Validation Science

 

How to Receive the Certificate when you've completed the courses:

Submit the following items to the RAQA Office (hard copy only).

1. Application 

2. Photocopies of your undergraduate and graduate transcripts.

3. A transcript from Temple's Banner system of courses taken in the RAQA program.

4. Notice of Completion

All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will 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.

Note:  Students may obtain only one certificate before completing the MS program, except for Food RA and QA.

 

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