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BSA regulations require all financial institutions to submit five types of reports. Individuals or companies must file an individual filing requirement. We will go over more details later on in this presentation. They are: Currency transaction reports (CTR) ...
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...
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 ...
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 ...
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 ...
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 ...
Organizations often use internal or external change management experts to help the organization create effective change management programs and plans. However, these change management experts often engage with key stakeholders without a plan to provide change ...
Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.