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ComplianceOnline

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn statistical methods related to ICH guidelines and will discover how regulatory agencies, such as the FDA expect organizations to meet these guidelines.

ICH Quality Guidelines seminar, Statistical Considerations seminar, ICH guidelines, pharmaceutical manufacture, biotech manufacture, statistical methods, ICH guidelines compliance, statistical methods tools, statistical methods templates, regression analysis, confidence intervals, tolerance intervals, appropriate sample size, risk probability, process characterization for design space, FDA regulatory requirements

Biotechnologie,    Pharmakologie und Arzneimittelentwicklung