Pharmaceutical Quality by Design MSc/PG Dip/PG Cert

Program Overview

The Pharmaceutical Quality by Design MSc/PG Dip/PG Cert program provides students with a comprehensive understanding of pharmaceutical science and technology, focusing on product development and manufacturing. It equips graduates with the knowledge and skills to pursue careers in the pharmaceutical and healthcare industries, including product development, manufacturing, regulatory affairs, marketing, and clinical research. The program emphasizes Quality by Design principles and continuous improvement activities, ensuring graduates are well-prepared for the challenges faced by the industry.

Program Outline

Pharmaceutical Quality by Design MSc/PG Dip/PG Cert

Degree Overview

This program focuses on pharmaceutical science and technology, particularly its application to the product development cycle. It aims to equip students with the knowledge and skills needed to pursue careers in the pharmaceutical and healthcare industries, both in research and development.

Objectives:

• Provide students with a thorough understanding of the challenges faced by the pharmaceutical and healthcare industries.
• Equip students with modern product development and manufacturing solutions aligned with current industry best practices and QbD principles.
• Prepare students for a wide range of careers in the pharmaceutical and healthcare sectors, including product development, manufacturing, regulatory affairs, marketing, and clinical research.

Program Description:

• Students learn about pharmaceutical product development and formulation, advanced analytical sciences, material science, process engineering, and control.
• Strong industry links ensure the program’s content and delivery stay up-to-date with current industry practices and developments.
• Students have access to extensive industry-standard laboratories and specialized equipment for practical learning.

Outline

Program Content:

• Quality by Design Principles: Explores legislation and regulations related to pharmaceutical product quality.
• Product Design: Formulation Development: Introduces techniques and methods for formulating and producing safe medicines.
• Process Design: Manufacturing & Process Analytical Technologies: Covers process design and control, understanding material properties, critical process parameters, and the role of process analytical technologies.
• Dissertation: Allows students to conduct research or development projects related to pharmaceutical manufacturing.

Program Structure:

• The program runs for one year full-time, with 15 contact hours per week on average.
• Modules are delivered in blocks, focusing on specific areas.
• The current program structure includes 6 blocks:
• Block 1: Quality by Design: Fundamental principles (30 credits)
• Block 2: Prod Design: Formulation Development (30 credits)
• Block 3: Process Design: Manufacturing & Process Analytical Technologies (30 credits)
• Block 4: Biopharmaceuticals (30 credits)
• Block 5 & 6: Dissertation (60 credits)

Module Descriptions:

• Quality by Design: Fundamental principles (Block 1): Explores a variety of legislation and regulations relating to the quality of pharmaceutical products.
• Prod Design: Formulation Development (Block 2): Introduces a variety of techniques and methods to formulate and produce safe medicines.
• Process Design: Manufacturing & Process Analytical Technologies (Block 3): Designs and controls the manufacturing process based on the understanding of material properties and critical process parameters.
The role of process analytical technologies in process identification, simulation, and control.
• Biopharmaceuticals (Block 4): Covers the use of large molecules, including those derived from biotechnology and especially those that are biologically active to produce therapeutic responses.
• Dissertation (Block 5 & 6): Aims to provide each student with an opportunity to consolidate their knowledge of quality by design applied to pharmaceutical science by carrying out a research or development project in an area directly related to pharmaceutical manufacturing.

Assessment

• The program uses assessment methods relevant to a master's level of study.
• Assessments include:
• Oral presentations
• Group assignments
• Case study reports
• Essay writing
• Research proposal
• Final dissertation

Teaching

• The learning environment consists of lectures, tutorials, seminars, laboratory practicals, and computer laboratories.
• In the third semester, the learning venue may shift towards guided self-study depending on the dissertation topic.
• Students typically have 15 contact hours of teaching per week, including:
• 1 hour of personal tutorials/small group teaching
• 4 hours of practical classes, workshops, or seminars
• 10 hours of lectures
• 10 hours of independent study
• The program features major research projects supported by Innovate UK and EPSRC (Engineering and Physical Sciences Research Council).
• The program has received substantial funding for developing advanced laboratories and equipment, matching those found in leading industrial laboratories.
• The program boasts faculty with extensive academic and industrial experience in various fields, underpinning the QbD principles.

Careers

• This program equips graduates with the knowledge and skills necessary to pursue careers in the pharmaceutical and healthcare sectors across diverse areas:
• Product development
• Manufacturing
• Regulatory affairs
• Marketing
• Clinical research
• Potential career options include:
• Product Lifecycle Manager
• Oral Solid Dose (OSD) Technologist
• OSD Industrialisation Lead
• Production Technologist
• Senior analyst
• Regulatory affairs associate performance manager
• Senior device technologist
• Product development scientist

Other

• Block teaching allows students to focus on one subject at a time, enabling greater engagement and regular feedback.
• The program offers strong links with industry, featuring guest lectures and contributions from experts in the field.

UK

EU/International Course code: H81271 Duration: One year full-time Attendance: This is a full-time programme with an average of 15 contact hours per week (please note this is subject to change). Start date: September 2024 Location of study: De Montfort University Leicester UK Fees and funding: 2024/25 tuition fees for UK students: £7,050 Find out more about additional costs and optional extras associated with this course. Please visit dmu.ac.uk/international for more information or call us on +44 (0)116 2 50 60 70. How to apply Application guidance document Submit a study-related enquiry Course code: H81271 Duration:One year full-time Attendance: This is a full-time programme with an average of 15 contact hours per week (please note this is subject to change). Start date: September 2023 Location of study: De Montfort University Leicester UK Fees and funding: 2024/25 tuition fees for EU and international students: £16,800 Find out more about additional costs and optional extras associated with this course. Please visit dmu.ac.uk/international for more information or call us on +44 (0)116 2 50 60 70. How to apply Application guidance document Submit a study-related enquiry