The life sciences industries are going through tremendous changes that have been increased by the recent global financial challenges. In order to help pharmaceutical and biotech companies improve their operations, the FDA is promoting the use of Quality-by-Design (QbD). Much work has been done on the QbD concept of a “design space” from a manufacturing process perspective but little has been done on using QbD in formulation development including the development of formulation design spaces. Formulation studies typically involve the optimization of multiple ingredients including the API, lubricants, binders, disintegrants, etc. Such optimization can be seen as a difficult challenge when a large number of components are involved which the case is typically.
A strategy based on QbD principles that have been proven to effectively and efficiently develop useful multi-component formulations is presented in this webinar. A critical goal is the creation of formulation understanding and design space that will consistently produce a product that meets specifications with minimal risk of failure. This strategy will be described and discussed along with several examples of its use.
Areas Covered in the Session :
- Approaching the development process from a strategic viewpoint, with the overall end in mind.
- Designing screening experiments to identify those components that are most important to the performance of the formulation.
- Designing optimization experiments to identify the optimum responses in the design space.
- Analyzing both screening and optimization experiments using graphical and numerical methods.
- Design space construction and associated risk analysis
- Optimizing multiple criteria, such as the quality, cost, and performance of product formulations.
- Designing and analyzing formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%.
- Guiding principles and tips and traps
Who Should Attend:
- Executives and Managers engaged in Pharmaceutical and Biotech Research and Development
- Quality Assurance Personnel
- Regulatory Affairs Professionals
- Test Method Development and Validation Personnel
- Quality Engineers
- Process and Manufacturing Engineers
- Research and Development Scientists
- Operations Excellence Professionals
- Biologists and Microbiologists
- Chemists and Chemical Engineers
- Everyone who is responsible for strategizing Speeding Up Formulation Development
Course Director: DR. RONALD D. SNEE
Ronald D. Snee, PhD, is Founder and President of Snee Associates, LLC. He provides guidance to senior executives in their pursuit of improved business performance using Lean Six Sigma, Quality by Design (QbD), and other data-based improvement approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Human Genome Sciences, and Kraft Foods.
Ron also serves as Adjunct Professor in the Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering Program. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceuticals.
He received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.
Ron in an Honorary Member of the American Society for Quality and has been awarded the ASQ’s Shewhart, Grant and Distinguished Service Medals. Other awards and honors include the American Statistical Association’s Deming Lecture, W. J. Dixon Statistical Consulting Excellence and Gerald J. Hahn Quality and Productivity Achievement Awards. He is a frequent speaker and has published six books and more than 300 papers in the fields of performance improvement, quality, management, and statistics.
He is a past recipient of the Institute of Validation’s Speaker of the Year Award.