ComplianceOnline

This webinar will show how you can perform meaningful, results driven 510(k) / change analysis activities and reporting so as to satisfy FDA requirements.

This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.

In this Failure Mode and Effects Analysis training, learn how you can design medical devices that enhance reliability, durability, safety, and serviceability. Get a solid understanding of both the Design FMEA, and the Process FMEA.

This Medical device training will be discussing 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.

This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.

This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback.

This training on adaptive designs for clinical trials will help you indentify situations in which adaptive designs would be advantageous and describe the operational and administrative changes to trials under various adaptive designs.

This webinar will help you understand the compliance requirements for running clinical trials in paediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in paediatrics.

This webinar will clearly explain the regulatory requirements (FDA, USP, ICH, EMA) for Validation of Analytical Methods and Procedures and present practical approaches for implementation.

Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan.