Live eLearning - PDA 738 Economical Design of Lyophilization Experiments - How to Get Real Return on Your Investment
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This 3-day training course is an introduction to an economical Design of Experiments (DoE) approach using lyophilization as the case study. Attendees will learn how to design an experiment to demonstrate that a fully developed freeze-drying process is little affected by the presence of variation in critical process parameters (CPP) and that the critical quality attributes (CQA) meet their specification criteria.
In contrast to the common burdensome and wasteful approach, this training course will focus on the economy of the DoE and give a practical experience of the process to create the attendees’ own experiments and reports.
- Demonstrate a working understanding of economical approaches to DoE which can be shared with their work group
- Explain how to do more with the same investment or less
- Identify the process variables and process steps of freeze drying and their criticality to develop a strategy for qualification, validation, annual product review, and discrepancies
- Connect statistical concepts to federal and ICH regulations
Agenda
Discover What's Happening Each Day
Tuesday, August 25, 2020
Confounding?
How to get more out of a DoE with the same or less work and the very minimum investment of time, materials, and human resources.
Picturing the Process
All too often we launch into a Risk Assessment by focusing on the details without any expectation that they will be used. This session will be conducted in a lab with hands on experiments to identify critical quality attributes, create a mental model of the system, and capture failure modes to prioritize parameters in our experiment.
Wednesday, August 26, 2020
Getting Excited about Nothing
Pharma’s statistically unlike other Industries. In a business where there are large volumes, low costs, and low risk, experimenters are searching for the smallest of changes because they mean increased profits and competitive advantage. Pharma, however, has relatively small volumes, high cost, and high risk. In our case we are proving that there is no change in the product. Several drivers may be at play in the exorbitant costs of CMO DOE’s but one of them is certainly a sponsor’s statistical inexperience causing a fear of building a case upon process knowledge versus the relative anonymity of the p-value.
Thursday, August 27, 2020
From the Lab to Manufacturing Floor to the Executive Suite and Back Again
Applying the knowledge gained to streamline regulatory interactions, to handle process deviations, to handle complex post-market approval changes, and to train new people, to communicate to the executives and to take that message back to the organization.
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Pricing Options
Standard Registration
Member Price
$600GovernmentMember Only
$600
Health AuthorityMember Only
$600
AcademicMember Only
$600
Non-Member
$600
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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