Validation Science Certificate (Pre-Master's) (RAQA)

Measured Precision and Quality Assurance

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 encompasses 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 for professionals working in a regulated industry who need theoretical, practical, and hands-on knowledge of various validation principles. After completing the 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)

And three electives:

  • 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.

All courses may be completed online. This certificate allows students to explore QA and RA issues without committing themselves to the entire Master of Science program. The GRE is not required for the Validation Science Certificate. 

All courses taken for the Validation Science Certificate will count toward the MS degree, as long as students are eligible for admission to the RA and QA master's degree and apply to the MS program before completing their third course. Students may obtain only one certificate before completing the MS program, except for Food RA and QA.

Application Information for RAQA Pre-Master's Certificates

Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal. 

Application Process for RAQA Pre-Master's Certificates
  1. Call the RAQA office at 267-468-8560 to speak with a program representative
  2. Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up. 
  3. Complete all of the required personal information in the Application Portal.
  4. Submit all required documents, as listed below. 

Once all documents have been received, your application will be submitted to our review panel for evaluation. A representative will be in touch within a week of submitting your application with a timeline for an admissions decision. 

Application Requirements for RAQA Pre-Master's Certificates
  • A baccalaureate degree, with an undergraduate GPA of 3.0 or higher.
  • Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to . Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy. 
  • Resume: Current resume or CV is required.
  • Statement of Goals: In approximately 500 to 1,000 words, applicants should state their specific interest in Temple's program, research goals, future career goals, and academic and research achievements.
  • Standardized Test Scores: Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master's degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:
    • TOEFL iBT: 85

Questions?

Reach out to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.

Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance
425 Commerce Drive, Suite 175
Fort Washington, PA 19034
267-468-8650
QARA@temple.edu