The Indian Drug Manufacturers’ Association (IDMA) & SSA Business Solutions will be organising a training programme on “Pharma QbD – a 360 degree view on Quality by Design (QbD)" on October 31, 2012 at Hotel Suba International, Andheri East, Mumbai.
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasises product and process understanding based on sound science and quality risk management.
From January 2013, the US FDA expects generic drug manufacturers to implement QbD into their Abbreviated New Drug Applications (ANDA), Module 3 Quality 3.2.P.2 Pharmaceutical Development.
Experienced personnel from the industry will provide a good understanding of statistical, analytical and risk assessment methods required for new drug application. They will also describe the way to implement this new approach.
The implementation of QbD can give manufacturers much more confidence in the robustness of their product, potentially increase the efficacy and quality of their development and manufacturing process as well as reduces profit leakages.
The training programme will be beneficial for those who are associated with production department, R&D, regulatory affairs, quality assurance and quality control, analytical development, pharmaceutical product development, engineers and others involved in making safe & effective medicines and all technical heads.
This will enable a participant to understand the QbD approach of new drug development, interpret ICH guidelines for QbD implementation for generics, understand application of QbD using a case example and a brief understanding of future CMC trends.