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Pharmaceutical Manufacturing: Process Development and Analysis Certificate

The Pharmaceutical Manufacturing: Process Development and Analysis CertificateÌýin the at 51¶¯Âþ enhances students’ understanding of the science and regulations involved in pharmaceutical manufacturing processes. Students will learn how to set standards for increasing product quality, improvingÌýplant efficiency, loweringÌýproduction costs, and meeting current domestic and global compliance requirements. This certificate is part of the school’sÌý.Ìý

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,Ìýchanging 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.Ìý

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.

Scheduling the Certificate

The Pharmaceutical Manufacturing: Process Development and Analysis Certificate is only available in a traditional classroom format at the RA and QA site in Fort Washington, Pennsylvania. Courses can be video-conferenced to corporate sites but are not available online.

The majority of courses are offered on weekends, which meet all day for either six Saturdays or six Sundays every two weeks. Some Pharmaceutical Manufacturing: Process Development and Analysis Certificate courses are offered on weeknights. One of the key required courses, Unit Operations, features two mandatory field trips to a Philadelphia-based manufacturing facility. While four of the classes can be video-conferenced, students must participate in the two manufacturing facility field trips.

Learning ObjectivesÌý

Through hands-on and theoretical approaches, students will expand their knowledge of science and engineering principles with information about current regulations. The certificate covers best practices for process development and analysis.ÌýÌý

Upon completion, students will understandÌýÌý

• control analysis and charting via statistical means;ÌýÌý

• control and monitoring;ÌýÌý

• unit operations of modern pharmaceutical manufacturing;

• various ICH quality guidelines and the basic scientific principles that may influence implementation;

• fundamentals of QbD; and

• fundamentals of Six Sigma, a data-driven methodology for minimizing variability.ÌýÌý

To receive the certificate, candidates must complete the required courses and application procedures.Ìý

Post-master’s Certificate

Students have the option to complete a post-master’s curriculum in pharmaceutical manufacturing: process development and analysis. To apply for this 12-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biochemistry, biology, chemistry, physics or a health-related discipline.

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Program Format & Curriculum

The Pharmaceutical Manufacturing: Process Development and Analysis Certificate may be earned on its own or on the way to the MS in RA and QA.ÌýÌý

To earn the certificate, the following four courses must be successfully completed within a three-year period with an overall B (3.0) average. There are three required courses. It is suggested that students take courses in the order listed below, if possible.ÌýÌý

• Unit Operations (5622) (must be taken prior to 5629)Ìý

• Process Monitoring (5629)Ìý

• Statistical Design of Experiments (DOE) (5627)ÌýÌý

One elective must be completed from the following choices.ÌýÌý

• Process Analytical Technology (PAT) (5625)Ìý

• Microbiological Concepts in Pharmaceutical Manufacturing (5512)ÌýÌý

• Risk Management for Pharmaceuticals and Medical Devices (5548)Ìý

Students must complete any required prerequisites to pursue RA and QA graduate-level courses.Ìý

All courses must be completed from 51¶¯Âþ’s RA and QA graduate program. No transfer credits from other institutions are accepted.ÌýTo receive the certificate, candidates must complete the required courses and application procedures.Ìý

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RequirementsÌý

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

• 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 51¶¯Âþ’s .

Learn more about the application process.Ìý

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS