Quality by Design (QbD): Successful Implementation for Pharmaceutical Development & Manufacturing
The FDA introduced Quality by Design (QbD) to help pharmaceutical and biotech firms reliably produce high quality drug products without extensive regulatory oversight. QbD also helps life sciences firms meet the competitive challenges of the global marketplace. Experience has shown that QbD can be effectively applied in manufacturing as well as research and development. Stage 3 of the FDA Process Validation Guidance (January 2011) calls for continued process verification of pharmaceutical manufacturing processes. Such a system relies heavily on QbD. The concepts, methods and tools of QbD can help create GMP systems that assure that manufactured products are of high quality and do not pose risk to the patient. This includes systems for manufacturing, testing and quality assurance.
In the years since the FDA outlined the concept of QbD pharmaceutical companies have been slow to adopt QbD. At the bottom of that resistance there may lie something deeper: fundamental lack of knowledge, skills and understanding of QbD.
You have decided to use Quality by Design (QbD) to improve product safety and efficacy. You are now faced with several questions. What do I do? What experimental work is needed? What skills are needed by the organization? This session provides these critical answers. Experimental studies needed to implement QbD are reviewed, and the skills needed to implement these studies are detailed. QbD training programs and their delivery are also outlined, with an emphasis on designing training for busy adult learners.
Attend this live, interactive 90-minute session and you will learn:
- The core principles of QbD in a GMP environment – taking a proactive approach to increase product quality, ensure compliance, and reduce risk
- Effective strategies and skills needed for successful implementation in a GMP environment
- How to design and deliver effective QbD training experiences
- Guiding principles for effective skill-building including tips and traps
Using case studies and examples, typical misconceptions will be debunked and a holistic approach to QbD will be presented.
This course will be extremely beneficial to those in the following roles:
- Department Directors and Managers
- Trainers and Training Organizations
- Compliance Scientists
- Research and Development Scientists
- Manufacturing and Process Engineers
- Quality Assurance Personnel
- Biologist, Microbiologists and Chemists
Ronald D. Snee, PhD is Founder and President of Snee Associates, LLC, 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. 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 2 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 has been awarded ASQ’s Shewhart and Grant Medals, and ASA’s Deming Lecture Award as well as numerous other awards and honors. He is a frequent speaker and has published 5 books and more than 245 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.