Overview:This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. Why should you Attend:Learn a methodology to perform experiments in an optimal fashionReview the common types of experimental designs and important techniquesDevelop predictive model...

Overview:In this session you will learn procedures and practices on how to validate and use Excel® requirements , and how to design spreadsheets for compliance , also how to ensure and validate spreadsheet integrity. Areas Covered in the Session:How to design spreadsheets for complianceHow to ensure and validate spreadsheet integrityWhen, what and how much to test?Validation of standard/native Excel functions? Who Will Benefit:QA Managers...

Overview:Refund PolicyBy attending this webinar you will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems. Why should you Attend:You will waste precious time and money and still end up with unsatisfactory results. This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years' experience. Areas Covered in the Session:Build the...

Overview:FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Why should you Attend:To gain a fundamental understanding of FDA's regulation of Dietary Supplements. Areas Covered in the Session:Definition of dietary supplementDSHEAGood Manufacturing PracticesStructure/Function ClaimsHealt...

Overview:The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Why should you Attend:Almost all manufacturing companies spend time and money to inspect purchased parts upon receipt, in order to evaluate part quality before the parts Supplier is paid. "AQL" sampling plans are used almost...

Overview:This webinar removes that confusion between equipment Qualification, process validation and Facility commissioning. Why should you Attend:The Webinar is designed for Quality and Manufacturing in the Pharmaceutical and Biopharmaceutical industries. Areas Covered in the Session:Quality Risk Management DefinedCompliance Requirements for Quality Risk ManagementThe Quality Risk Management ModelQuality Risk Management Life Cycle Who Will Be...

Overview:The presentation will explain that how to establish processes for addressing problems and conflicts that occur during the project , and how to apply these processes to a system implementation that has failed. Why should you Attend:Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality. Areas Covered in the Session:Best practice for Creating a NotebookRestructuring and Rearra...

Overview: We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager. Why should you Attend: On average it takes ten successful projects to make up for one really bad project. If your projects are finishing late, if your teams turn over faster than a freshman class in college, if your projects are losing money, then you need to take this course. Areas Cover...

Overview:Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators. Why should you Attend: Perhaps you're a development manager, hoping to improve both productivity and quality. Or you are a quality assurance manager, facing a demand from management and development to permit a move to Agile. Areas Covered in the Session:TIR 45 comes at a much ne...

Overview:The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Why should you Attend:How to Build a Compliance StrategyMinimizing Cost while Maximizing ComplianceKnowing the policies and procedures that must be developed and maintained to support the clinical trial system in operation Areas Covered in the Session:FDA T...