Pharmaceutical Manufacturing: Process Development and Analysis Graduate Certificate Postgraduate Programme By Temple University |TopUniversities
Subject Ranking

# 351-400QS Subject Rankings

Main Subject Area

Pharmacy and PharmacologyMain Subject Area

Programme overview

Main Subject

Pharmacy and Pharmacology

Degree

Other

Study Level

Masters

Study Mode

On Campus

The Pharmaceutical Manufacturing: Process Development and Analysis Certificate in the School of Pharmacy at Temple University enhances students’ understanding of the science and regulations involved in pharmaceutical manufacturing processes. Students will learn how to set standards for increasing product quality, improving plant efficiency, lowering production costs, and meeting current domestic and global compliance requirements. This certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program. 


The Pharmaceutical Manufacturing: Process Development and Analysis Certificate was first launched in 2006, in response to the Food and Drug Administration’s (FDA) 2002 initiative to enhance the regulation of pharmaceutical manufacturing and product quality, bringing a 21st-century focus to this agency responsibility. The RA and QA graduate program relaunched the certificate in 2019, changing it to four courses and renaming it the Pharmaceutical Manufacturing: Process Development and Analysis Certificate. The current curriculum reflects the culture of continuous manufacturing quality, such as


  • the FDA’s quality metric guidance document and its focus on data integrity;
  • change control;
  • quality risk management; and
  • installation, operational and performance qualifications. 


Students begin the Certificate in Pharmaceutical Manufacturing: Process Development and Analysis with the Unit Operations (5622) course, which reviews the steps and processes used in modern pharmaceutical manufacturing and includes hands-on workshops at a Philadelphia-based manufacturing facility, where students mill and process tablets. The program’s Process Monitoring (5629) course discusses why process control is integral to quality by design (QbD) and touches upon lean and Six Sigma, including discussions on when it should or should not be applied. The final capstone course, Statistical Design of Experiments (5627), reviews statistical methods used in designing optimal processes for industry, which concludes with students designing an experimental plan to optimize a process.

Programme overview

Main Subject

Pharmacy and Pharmacology

Degree

Other

Study Level

Masters

Study Mode

On Campus

The Pharmaceutical Manufacturing: Process Development and Analysis Certificate in the School of Pharmacy at Temple University enhances students’ understanding of the science and regulations involved in pharmaceutical manufacturing processes. Students will learn how to set standards for increasing product quality, improving plant efficiency, lowering production costs, and meeting current domestic and global compliance requirements. This certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program. 


The Pharmaceutical Manufacturing: Process Development and Analysis Certificate was first launched in 2006, in response to the Food and Drug Administration’s (FDA) 2002 initiative to enhance the regulation of pharmaceutical manufacturing and product quality, bringing a 21st-century focus to this agency responsibility. The RA and QA graduate program relaunched the certificate in 2019, changing it to four courses and renaming it the Pharmaceutical Manufacturing: Process Development and Analysis Certificate. The current curriculum reflects the culture of continuous manufacturing quality, such as


  • the FDA’s quality metric guidance document and its focus on data integrity;
  • change control;
  • quality risk management; and
  • installation, operational and performance qualifications. 


Students begin the Certificate in Pharmaceutical Manufacturing: Process Development and Analysis with the Unit Operations (5622) course, which reviews the steps and processes used in modern pharmaceutical manufacturing and includes hands-on workshops at a Philadelphia-based manufacturing facility, where students mill and process tablets. The program’s Process Monitoring (5629) course discusses why process control is integral to quality by design (QbD) and touches upon lean and Six Sigma, including discussions on when it should or should not be applied. The final capstone course, Statistical Design of Experiments (5627), reviews statistical methods used in designing optimal processes for industry, which concludes with students designing an experimental plan to optimize a process.

Admission Requirements

110+
79+
6.5+
53+
  • Candidates must formally apply, following the application procedures (application form, photocopies of transcripts and Notice of Completion). 
  • Only one certificate may be completed before students receive the RA and QA MS.
  • The certificate must be completed within three years.
  • To receive the certificate, students must submit the Notice of Completion within one year of completing all required coursework for the program.
  • Students interested in pursuing the MS in RA and QA may apply all credits earned from the Pharmaceutical Manufacturing: Process Development and Analysis Certificate toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school.

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Aug

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