| Overview Recent emphasis on Quality by Design (QbD) has seen increased use of statistics in pharmaceutical development and manufacture. The benefits of statistical methods extend beyond compliance. Statistical thinking and application provide substantial business and patient benefit by speeding and strengthening product and process understanding, managing risk, and ensuring acceptable process performance. The application of statistics to biopharmaceutical processes can present challenges due the nature of the process and data available. This one day workshop will be run by an ISPE international Instructor who is a qualified statistician with deep experience in application of statistical techniques to pharmaceutical manufacturing. The subjects to be covered in this workshop will include - Design of Experiments to enable Quality by Design and determine the optimal control strategy
- Sampling and acceptance criteria for
- Establishing specifications
- Comparability studies
- Homogeneity
- Process Validation/PPQ
- Ongoing monitoring (Design of an effective CPV/OPV program)
- Data visualization
- Common pitfalls in the use of statistics with biopharmaceutical manufacturing
Take Back to Your Job: - Examples of practical application of statistical methods and techniques as applied to biopharmaceutical manufacturing
- Experience and insights from an experienced pharmaceutical statistician on the use of statistical tools in manufacturing quality and validation applications
- Deeper understanding of the use of statistics for QbD
Who should Attend? Quality personnel, product development staff, validation SMEs, regulatory affairs and technical professionals, managers who plan, develop or manage scale up; or commercial manufacture of biopharmaceutical products. Presenter: Tara Scherder has over 20 years of experience in the pharmaceutical and biopharmaceutical industries as a statistician, process engineer, and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize both manufacturing and business processes and reduce risk. She combines statistical expertise with extensive knowledge of manufacturing platforms, and analytical sciences, in conjunction with business and regulatory acumen to achieve goals. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams from product development through commercial supply for a wide spectrum ofproduct platforms. Tara is an ISPE instructor and frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation. She earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University. As principal at SynoloStats, she passionately collaborates with teams to leverage statistical methods to accelerate timelines, design and develop robust processes, and assure ongoing quality to patients and consumers. Agenda 08:45 - 09:00 Registration 09:00 - 09:15 Welcome & Introductions 09:15 - 10:00 Introduction to statistics and statistical techniques 10:00 – 10:30 Control strategy – The utility of Design of Experiments (DoE) techniques in determining optimal control strategies 10:30 - 11:00 Break 11:00 - 11:45 Control Strategy and DoE continued 11:45 - 12:30 Sampling design and statistical acceptance criteria for biopharmaceuticals 12:30 – 13:30 Lunch 13:30 - 14:15 Sampling design and statistical acceptance criteria continued 14:15 - 15:00 Application of statistics to CPV/OPV 15:00 - 15:30 Break 15:30 – 16:30 Data visualization and common pitfalls with use of statistics 16:30 - 16:45 Wrap Up & Close | 
