Validation Science Certificate

The Validation Science Graduate Certificate in the School of Pharmacy at Temple University provides a strong foundation in validation principles for both experienced professionals and those seeking entry into this career field. The certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program.  

Validation science is a multidisciplinary activity that includes engineering, chemistry, microbiology, pharmacology, information technology and statistics as applied to the development, production, distribution and monitoring of products regulated under the U.S. Food, Drug and Cosmetic Act. It encompasses numerous activities that are done to demonstrate and document that products, processes and systems are reliable, reproducible and perform as expected. Its concepts are applied to a broad spectrum of activities, such as systems, facilities, utilities, equipment, test methods, processes, data and final products. The field is constantly evolving in a dynamic regulatory, economic and scientific environment. 

The certificate explores validation science in a global environment, combining key regulatory, scientific and analytical concepts that define the field. Students completing the Validation Science Certificate will understand and be able to apply the benefits, principles and concepts associated with validation science. They will also become familiar with the domestic and international regulations governing the discipline. 

Learning Objectives 

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

• 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 in the development of verification and validation requirements

Post-master’s Certificate in Validation Science

Students have the option to complete a post-master’s curriculum in validation science. This post-master’s certificate provides students with a strong foundation in validation science principles, whether the student is an experienced professional or someone seeking entry into the career field. To apply for this 15-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor’s degree from an accredited institution.

Learn more about the Post-master’s Certificate in Validation Science.

Program Format & Curriculum  

The Validation Science Certificate may be earned on its own or on the way to the RA and QA MS. To earn the certificate, five of the following courses must be successfully completed within a four-year period with an overall B (3.0) average.  

There are two required courses.  

• Process Validation (5474)

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

Choose three elective courses. 

• 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 (current good manufacturing practice regulations). Students without such knowledge should consider taking the Good Manufacturing Practices (5477) course before beginning the certificate. Students should start the certificate with the Process Validation (5474) or Validation of FUE (Facilities, Utilities and Equipment) (5468) courses; however, those with prior educational or professional experience in validation science may begin with an elective. 

Learn more about the Validation Science Certificate.

See the curriculum.

Requirements 

• Participants must have a bachelor’s-level degree from an accredited institution of higher learning. While no specific major is required, most applicants should have a background in healthcare, natural science, biological sciences, engineering or related disciplines.

• All courses must be completed from Temple University’s RA and QA graduate program. Transfer credits from other institutions are not accepted.

• GREs are not required for the certificate.

• Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and Notice of Completion).

• Only one certificate may be completed before students receive the MS.

• Students should complete the certificate courses within four years. Students must apply for the Validation Science Certificate within one year of completing the five courses in the program. 

• Students interested in pursuing the RA and QA MS program may apply all credits earned from the Validation Science Certificate towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school.

Learn more about the application process.

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS