Welcome to QbD in Pharma Development 2013 Knowledge / Training Seminar
Quality-by-Design (QbD) has now become a buzzword in pharma circles. The federal agencies are reiterating to build quality into the products during multi-phase product development life cycle and eventually, enhance product and/or process understanding, all using the rational and systematic approach of QbD. The key elements of QbD include the QTPP, CQAs, QRM, design space, control strategy and continuous improvement, as enumerated in the ICH guidelines, Q8, Q9, Q10 and Q11. The key regulatory agencies across the globe like US FDA, WHO, EMEA, Health Canada, MHA, TGA, PMDA and SFDA have adopted such ICH guidance per se. Besides being a federal requirement, QbD is fast emerging as a tangible tool to quicken time to reach market, reduce recalls and rejects, improve patient generic scepticism, minimise post-approval changes, streamline data flows across the entire life cycle of the drug, and above all, improve overall efficacy and cost-efficacy for patients and manufacturers alike.
One of the most vital elements of QbD is Design of Experiments (DoE), wherein a sound experimental strategy is contemplated as a prelude to the experimental studies. As DoE has much wider domain of application permeating myriad disciplines beyond even the pharma sector, a terser jargon, viz. “Formulation by Design (FbD)”, has been in rampant use, applicable specifically to the integrated use of DoE and QbD in optimized drug product development.
This Seminar will offer definitive benefits to the scientists from academia and industry working in the domains of Product Development, Process R & D, Scale-up, Manufacturing, Quality Assurance, Global Regulatory Affairs, API, Excipients, Pharmaceutical Analysis and Technology Transfer.
The speakers will articulate on all the pertinent areas of QbD including: Federal Requirements, QbD for API & Excipients, QbD in Analytical Development, Prioritization using QRM, FMEA & Screening Designs, QbD in Product Development using FbD, FbD & DoE using pertinent software packages, Key issues in earmarking design and control spaces, FbD Implementation using Optimization designs and QbD/FbD Case Studies.
Running alongside the Seminar / Workshop will be an exhibition covering the latest techniques available for successful implementation of QbD in Pharmaceutical industry.