GlobalCompliancePanel

A how to guide to meeting customer expectations of the maintenance function. An overview of industry best practices and a review of some leading software solutions.

This presentation will describe a proven process for preparing a site for inspection of systems.

In this presentation, we will review recent medical device manufacturers Warning Letters to determine the inadequacies of responses by manufacturers.

The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so.

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance.

The purpose of auditing is to identify failures in the system or gross negligence.

To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly.

In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns

This webinar will examine the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system.