QbD in Pharma Development
24 Feb 2014 - 25 Feb 2014 - Mumbai, India
Excellence and Compliance using QbD.
This event is especially designed to discuss the implementation case studies, success stories and issues and challenges faced while implementing QbD principles at industry level.
The federal agencies have reiterated 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 including the QTPP, CQAs, QRM, CMA, CPP and control strategy, as enumerated in the ICH guidelines, Q8, Q9, Q10 and Q11, are to be followed and implemented. 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.
This event 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 Implementation including API, Analytical Development, Excipients and Formulation.
Running alongside the conference will be our “Generics and Biologics 2014” meeting