Time: September 28, 2017 at 9am to September 29, 2017 at 6pm
Location: DoubleTree by Hilton Las Vegas Airport
Street: Las Vegas, NV
City/Town: Las Vegas, NV
Website or Map: http://www.globalcompliancepa…
Event Type: online, healthcare, training, courses
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Jul 11
Course "Design of Experiments (DOE) for Process Development and Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product.
The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs, are used to determine critical process parameters. Response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs, are used to model the functional relationship between those critical process parameters and the critical quality attributes.
This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated.
Why you should attend:
The Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers provides guidance on where design of experiments should be applied during process validation; it suggests the use of both screening and response surface designs during Operational Qualification. In addition, DOE should be used during multiple phases of design controls: design and development planning, design verification, design validation, design transfer, and design changes.
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel