Become Certified Professional in Quality by Design (QbD)The certification covers all the statistical tools for QbD framework. The certification features with industry specialists and experts facilitating quality implementation in various industries. QBD implementation can give manufacturers much more confidence in the robustness of their product, potentially increases the efficiency and quality of their development and manufacturing process as well as reduces profit leakages. QbD elements include the following: (QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT).This certification will provide insight into the key principles of QbD covering quality risk management and formal experimental design. The certification is intended as continuing professional development (CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The certification will offer an excellent introduction for those less familiar with QbD and provide those with more experience with QbD, new ideas on how to further implement the QbD programme. The case study based approach in certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GMP professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certification having rigorous case studies based methodology throughout the duration. While quality by design principles have been used to advance product and process quality in industry, and particularly the automotive industry, they have also been adopted by the U.S. Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs. QbD Overview a US FDA initiative and its advantagesSince the introduction of Quality-by-Design (QbD) concepts, it has been accepted that quality of pharmaceutical products should be designed and built during the manufacturing process. Most of quality problems are related to the way in which a pharmaceutical product was designed. A poor-designed pharmaceutical product will show poor safety and efficacy, no matter how many tests or analyses have been done to verified its quality. Thus, QbD begins with the recognition that quality will not be improved by merely increasing testing of pharmaceutical products. In other words, quality must be built into the product. Quality by Design (QbD) is one of the most important initiative by US FDA. Pharmaceutical Quality for the 21st Century: A Risk-Based Approach in 2002 by FDA was the first step towards this goal of QbD compliance. Same period FDA issued another guideline on Process Analytical Technology (PAT) to guide the Generic Industry about the advantages of PAT in Real Time Release. This was the beginning of the journey towards implementing QbD. The concept is based on enhancement of Process & Product understanding with the help of Risk assessments, identifying Critical Quality Attributes & Critical Process Parameters to be monitored thru right control strategy. Customers are benefitted thru consistency in commercial manufacturing. FDA recommended the implementation since 2013.US FDA initiative on QbDQbD principles have been adopted by the US Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs. The FDA initiative is outlined in its report Pharmaceutical Quality for the 21st Century: A Risk-Based Approach (1). FDA has taken this initiative to guide the Pharmaceutical Industry on how to implement the concepts of QbD into its processes. The focus is on quality should be built into a product with an understanding of the product and process by which it is developed and manufactured with understanding risks involved in manufacturing the product and how best to manage those risks. This is improvement is over Quality by Testing (QbT), traditional approach, by the Industry. QbD facilitates design of products and processes that enhances the products Qurity, Efficacy and Safety in the interest of Patients. While QbD will provide design space (DS), the scale-up and commercial manufacturing experience provides knowledge about the process and the interactions
