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Regulatory Affairs & Quality Assurance

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Validation Science Certificate (Post-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.|

Required Courses:

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

Elective Courses (three of the following 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)

If students have completed one of the courses as part of their MS program, they should take another elective in its place.

Application Information for RAQA Post-Master's Certificates

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

Application Process for RAQA Post-Master's Certificates
  1. Contact the RAQA office 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 Post-Master's Certificates
  • A master’s degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields
  • You must apply before starting the program on the Graduate Application Portal. 
  • 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. It should also indicate which courses you would like to pursue, cite your industry experience, and include at least two alternate courses to allow for greater scheduling flexibility.
  • Standardized Test Scores: Applicants who earned their master's degree from an institution where the language of instruction was other than English, must report scores for a standardized test of English that meet these minimums:
    • TOEFL iBT: 85
  • Some certificates require proof of work experience in RAQA or Biosimilar Manufacturing. Please contact the RAQA Program Office for specific details. 

Questions?

Contact our office directly to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.