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

• the purpose, benefits, basic concepts and terminology of Validation Science;
• the domestic and international regulations, guidance documents, and standards associated with Validation Science;
• validation principles and concepts associated with pharmaceutical, biotechnology, medical device and other regulated industries;
• validation principles and concepts associated with facilities, utilities, equipment, processes, test methods, cleaning, computerized systems, and products;
• documentation necessary to support validation life cycle activities, including Validation Master Planning;
• scientific and statistical principles used in the development of verification and validation requirements.|

  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:

• Process Validation (5474)
• Facilities, Utilities, and Equipment Validation (5468)

Elective courses include (three must be completed)

• Statistical Quality Control (5451)
• High Purity Water Systems (5478)
• Production of Sterile Products (5492)
• Sterilization Processes (5493)
• Computerized System Validation (5498)
• Design Control for Medical Devices and Combination Products (5503)
• Cleaning Validation (5516)
• Statistical Design of Experiments (5627}
• Process Monitoring (5629)
• Special Topics (5650) (focusing on current validation issues)

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.