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If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof t ...
Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventin ...
This webinar aims to educate individuals about the impact of workplace wellness on their overall well-being and productivity. It will raise awareness about the importance of workplace wellness and the potential benefits it can bring to personal and professiona ...
This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...
As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting regulatory compliance requi ...
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements in per US and Europe. Annual Product Quality Review ...
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...
How do you know how well your suppliers are doing? Most responses present a subjective view. It is akin to throwing darts - sometimes you are close, but most times you are "off-target". You need a tool that will provide an objective, quantitative visibility ...
Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...
In this webinar, you will learn to use little-known Outlook features and advanced features that are hiding in plain sight. Not only will you learn about the features, but you’ll learn the benefits of those features from a time management viewpoint. Effective ...