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Introduction
No matter the industry, manufacturers that leverage fit-for-use statistical methods have a competitive advantage over those that don’t. The pharmaceutical industry is no different. The powerful combination of statistical methods and scientific knowledge can result in accelerated development timelines, improved process understanding, optimal processes, lower lifetime COGS, and reduced business and patient risk. Additionally, since the adoption of the lifecycle approach to process validation based on regulatory guidance, there has been an increase in expectation for rigorous evidence of product quality and process control. In this course, participants will learn the basics of the key statistical tools to ensure compliance plus reap the benefits of effective and efficient design of optimal processes, process robustness, and ongoing process control.
Who Should Attend
- Process Development teams.
- Manufacturing Science and Technology teams.
- Qualified and Responsible Persons (QPs, RPs).
- Validation and Qualification teams.
- Contract Manufacturing organizations (CMOs) and Contract Development and Manufacturing organizations (CDMOs)
Key Takeaways
Meet The Trainer
Tara Scherder has over 20 years of experience in the pharmaceutical industry as a statistician, process engineer, educator, and master black belt. As principal at SynoloStats, she passionately shares the opportunity for patient and business benefit through the powerful combination of statistics and science. She combines statistical expertise with extensive knowledge of manufacturing
platforms/analytical sciences and CMC requirements to increase knowledge, optimize manufacturing, analytical and business processes, and manage risk. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation.
Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.
