Practical and Value-added Statistics for the Non-statistician
Session 1: Using Design of Experiments (DOE) to define the process control strategy
Accelerated timelines, complex supply chains, data constraints, evolving compliance requirements… These are just a few of the challenges of today’s pharmaceutical industry. How can you leverage statistical methods to enable solutions to these challenges and become a more efficient developer and manufacturer? Based on your member survey responses, the Delaware Valley Chapter is presenting an educational series of practical and value-added statistical methods you can apply across the product lifecycle to reduce timelines and resources, increase knowledge, manage risk, and assure ongoing product quality.
Speakers:
Tara Scherder
Partner at SynoloStats LLC
Tara has over 20 years of experience in the pharmaceutical industry as a statistician, engineer and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize processes, and reduce risk to meet business and patient needs. She supports drug substance and drug product teams from product development through commercial supply for the spectrum of product platforms. She frequently speaks and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation. Tara earned a BS in Chemical Engineering from the University of Pittsburgh and an MS in Statistics from Carnegie Mellon University.
Katherine Giacoletti
Principal Scientist, Center for Mathematical Statistics at Merck & Co., Inc.
Katherine has over 20 years of experience as a statistician in the pharmaceutical industry, with expertise across the lifecycle, from process development through validation and commercial supply. Katherine is highly skilled in a wide range of statistical methodologies, with the knowledge to choose the best methodology to meet scientific and business demands. She is passionate about using statistical thinking to benefit patients and manufacturers and is a frequent speaker and instructor on using statistics across the product lifecycle. She holds a BA from Swarthmore College and a Masters of Statistics at North Carolina State University, with a focus in biostatistics.
Registration Information:
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COST |
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|---|---|
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ISPE Members |
$70 |
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Non-Members |
$90 |
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Emerging Leaders/Student |
$45 |
| Virtual Option: ISPE Members Only | $40 |
**Participants can earn 3 PDH credits for attending**