Strategies For Speeding Up Formulation Development

Why Should You Attend:

In this webinar, you will learn

HOW TO:

• Approach the development process from a strategic viewpoint, with the overall end in mind.
• Design screening experiments to identify those components that are most important to the performance of the formulation.
• Design optimization experiments to identify the optimum responses in the design space.
• Analyze both screening and optimization experiments using graphical and numerical methods.
• Construct Design spaces and assess and the associated risk
• Optimize multiple criteria, such as the quality, cost, and performance of product formulations.
• Design and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%

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.

Areas Covered in the Webinar:

• Strategies for Formulations Development
• 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%.

Who Will Benefit:

• R&D and Manufacturing Managers
• Research and Development Scientists
• Quality Assurance Personnel
• Quality Engineers
• Process and Manufacturing Engineers
• Biologists and Microbiologists
• Chemists and Chemical Engineers
• Supply Chain Professionals
• Those who desire to learn strategies for using designed experiments

From Pharma and Biotech Industries

Free Materials:

• Copies of slides of presentation

Ron Snee
Founder and President, Snee Associates

Ron Snee is Founder and President of Snee Associates, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceuticals.

While at DuPont he got involved in developing mixture and formulation systems which lead to the creation of several seminal advances for the effective design and analysis of mixture experiments. Snee has worked in the field for more than 40 years. His accumulated learnings have resulted in the recent book Strategies for Formulations Development – A Step-by-Step approach using JMP software, published by SAS Books, Cary, NC He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also coauthored 3 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering program.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science. He is an Honorary Member of ASQ and has been awarded ASQ’s Shewhart, Grant and Distinguished service Medals, and ASA’s Deming Lecture, W. J. Dixon Consulting and Gerry Hahn Quality and Productivity Achievement Awards. He is a frequent speaker and has published 7 books and more than 330 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award.

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