Many companies struggle with spreadsheet compliance. Some are still using invalidated spreadsheets. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to spreadsheets. This seminar will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements - - - - - - more details.

This presentation will explore how Design Validation must be conducted to avoid audit/inspection observations. We will review how Design Validation, Risk Management requirements for verification of risk control measures, and Process Validation are all linked together and must be properly performed to assure product is legally placed on the market - - - - - - more details.

Participants will create a new 510(k) application from beginning to end. A description of the tests and the results obtained are essential. This Webinar will introduce the participants and provide a real-life example on how to properly construct your application and ensure that all substantive details are provided - - - - - - more details.

This webinar will be highlighting the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products - - - - - - more details.

Clinical Study Reports (CSR) submitted to regulatory bodies in the drug development process must meet high quality scientific standards and be compliant with International Conference on Harmonization (ICH) standards. This webinar is designed to provide guidance for producing such a document - - - - - - more details.

This Product Labeling session will address what you need to do to ensure compliance. The label is a "display of written, printed, or graphic matter upon the immediate container of any article..." As a bonus, this session will also address SPL and one of the advantages of SPL (over the PDF format that FDA previously used) is that it will make exchange of labeling changes more efficient - - - - - - more details.

On September 27, 2007, the FDA Amendments Act of 2007 was signed into law. This act includes the requirement to establish a Unique Device Identification System or UDI. Draft regulations are being drafted by the FDA for public comment. Attend this UDI training to know What is the purpose of these changes? How will this impact your company and its distribution system? What steps should your company be doing right now to be in compliance - - - - - - more details.

The presentation provides an understanding of the relationship between classification of medical devices by manufacturers and the premarket processes affecting the product. The two major systems of medical device classification are reviewed to understand how classification impacts product development and design validation activities - - - - - - more details.

This course provides the participant with a clear and simple explanation of corrective action and preventive action systems. It cuts through the confusion by explaining the technical definitions of correction, corrective action, and preventive action. By laying a clear foundation, the presentation offers a solid approach to a Corrective and Preventive Action (CAPA) system implementation - - - - - - more details.

This course offers an opportunity for clinical researchers, industrial engineers, and healthcare professionals to gain an in-depth understanding of the regulatory process in medical device applications, as well as, the global regulatory framework as it relates to their product’s technology and market. This course provides comprehensive, up-to-date knowledge of regulatory processes contained in U.S. and international regulations, standards, and guidelines - - - - - - more details.