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This webinar will define what are the US FDA's expectations for the use of statistical techniques, e.g., 21 CFr 820.25, for establishing, controlling, and verifying the acceptability of process capability and product characteristics, sampling plan justificatio ...
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application ...
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 ...
In Excel, sometimes there is a need to look up information from a table or from a different sheet, or to link the sheets together.
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
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 ...
linical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health. Clinical trials are conducted acc ...
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...
The United States Food and Drug Administration (FDA) plays a crucial role in regulating medical devices to ensure their safety and effectiveness. In an effort to harmonize its regulatory framework with international standards, the FDA has proposed aligning its ...
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. Design control is not only a requirement of t ...