Diploma And Certificate Courses
This year, Punjab University College of Pharmacy is going to start Certificate program in Quality by Design (QbD) for professionals working in Industry and Research & Development. This would be a first ever Certificate program in any Pharmacy institutes in Pakistan. Other Certificate and Diploma courses for Pharmacy students and health Professionals will be started in future.
The certificate in Quality by Design (QbD) aims to provide each student an opportunity to consolidate their knowledge of QbD applied to pharmaceutical, health and other sciences by carrying out development or research projects in an area directly related to them using the appropriate software of Design Experiment.
· To explore a variety of legislation and regulations relating to the quality of Pharmaceutical and other products and processes.
· To introduce a variety of techniques and methods to formulate and produce optimized drugs/products/processes.
· To describe online process monitoring of manufacturing and the use of Process Analytical Technology (PAT) to advance pharmaceutical and industrial process identification, simulation and control.
· To introduce the concept of 6-sigma.
· To focus on research and experiment design methods applying QbD principles.
· To describe the concept and importance of design space.
R.s. 22000/- (for three months)
Full time, Evening, per week 3 lectures where the issues will be primarily illustrated through examples from industrial cases. Since the concept is understandable using and appropriate software for Design of Experiment, the students will also have basic training of the software.
Pharmacists, professionals working industries, Institutes of Research and Development, and Researchers in health sciences.
· Concept of computer aided formulation and process development
· Concepts of Quality by Design, Process analytical technique and. six sigma.
· Introduction of basic statistics relevant to Quality by Design
· Factor analysis using screening designs
· Optimization using response surface methodology
· Product design: pre-formulation and formulation
· Process design and manufacturing
· Experimental design and research methods
· Process Analytical Technique (PAT)
· Advances in drug delivery
· Introduction of the computer tool used in quality by design and process analytical techniques.
1. Reklaitis, G.V. (2016). Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture. Wiley-A1CliF, New Jersey USA.
2. Jameel, F., Hershenson, S., Khan M.A., and Sheryl Martin Moe. (2015). Quality by Design for Biopharmaceutical Drug Product Development. Springer-Verlag GmbH, Berlin, Germany.
3. Mark J. Anderson, and Patrick J. Whitcomb (2015). .DOE Simplified: Practical Tools for Effective Experimentation, 3rd Edition. Productivity Press, New York, USA.
4. Anurang, S. Rathore, and Rohin Mhatre. (2009). Quality by Design for Biopharmaceuticals, Principles and Case Study. .Wiley-A.I.ChE, New Jersey USA.
5. Eugene C. Nelson, Paul B. Batalden, and Marjorie M. Godfray, (2007). Quality by Design, A Clinical Microsystem Approach. Wiley-AIChE, New Jersey USA.
6. Lewis, G.A., Mathielf, R. and Phan-Tan-Luu. (1999). Pharmaceutical Experimental. Design, Marcel Dekker, New York, USA.
7. Lynn D. Torbeck (2007). Pharmaceutical and Medical Device Validation by experimental Design. Informa Healthcare, New York, USA.