GlobalCompliancePanel

Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result.

This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. .

In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition

This presentation will review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements.

The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output".

Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard.

Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose.

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs.

This program is intended for those personnel who are concerned with the analysis and correction of problems (deviations and failures).