QbD based Pharma Product Development

Held in conjunction with Nanomedicine

29 May 2013, at 12.30 in New Delhi, India

Who Should Attend
Scientists working in the domain of Formulation Development, Manufacturing, Scale-up, Quality Assurance, Formulation R & D, Regulatory Affairs, and specifically on Quality by Design (QbD) or Design of Experiments (DoE) saving a great deal of resources, i.e., time, manpower and money. The course will also benefit those working in the area of Optimization of API, Excipients, Drug Analysis or Technology Transfer. Researchers from academia too can harvest a great deal on these systematic and rational approaches to formulate “optimized” drug delivery systems in their laboratories

Course Significance
QbD has been the talk of the town not only in the developed world but in the developing nations like India too. The key federal agencies across the globe like US FDA, WHO, EMEA, Health Canada, MHA, TGA and SFDA have already adopted these ICH guidance’s like Q8, Q9, Q10, Q11 & PAT. Particularly, QbD paradigm has become a buzzword in the generic pharma trade, as all the products entering US market have to be QbD-compliant w.e.f. Jan. 1, 2013, as per the Office of Generic Drugs (OGD) of FDA. It is quite likely that WHO, ICH or FDA might also come up with definitive deadlines for innovative products too. Needless to mention, the endeavor of the regulatory agencies is to attain product development excellence meeting the desirable patient needs through comprehensive product and/or process understanding through QbD principles.

Learning Objectives
1. To familiarize the background of QbD and its nuances in the light of QTPP objectives
2. To gain the knowledge and knowhow on systematic approach of design of experiments (DoE) especially for product development, lately rechristened as Formulation by Design (FbD)
3. To accomplish awareness on the applicability of various experimental designs
4. To select vital few factors for prioritization of CQAs, CPPs and CMAs on the basis of screening, QRM or FMEA
5. To learn the significance of design and control spaces and the methods to earmark them
6. To go through various case studies on FbD & DoE using pertinent software packages