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Next Event: September 11-12, 2019 | Anaheim, CA
  • Understand the elements of the and how each subsystem is interconnected to the rest in order to meet GMP requirements
  • Conduct internal audits to monitor quality and apply corrective actions when appropriate
  • Evaluate SOPs, design controls, and validation protocols from a quality perspective and make revisions or improvements as needed
  • Organize and manage evaluation data to improve product quality and address customer complaints

Complying with FDA Requirements for Deviation Investigations

Next Event: September 10-11, 2019 | Anaheim, CA
  • Establish an investigation process flow that will insure consistency and thoroughness of the investigation and provide a better guidance document for remediation.
  • Provide a better understanding of how the components of the investigation work in conjunction with each other and the value that they provide. Such as: Root Cause Analysis, Corrective and Preventive Action, Interviews, Risk and Impact Assessments, Change Controls and Results Assessments.
  • Reduce the amount of time required by the Investigator in conducting the search for information needed in order to compile the investigation report.
  • Improve investigator confidence in the accuracy of the information being provided to determine the true root cause/causes of the deviation.

Improve Processing of Customer Complaints, Recalls and Field Alerts

Next Event: October 15-16, 2019 | New York City, NY
  • Streamline and improve the process for managing customer complaints, recalls, field alerts and agency responses.
  • Gain knowledge of the processes and tools that can be used to improve your ability to manage and maintain and insure consistent compliance with agency requirements.
  • Improve your understanding of the impact that comes with complaints, recalls and field alerts and insure that risk of reoccurrence is less likely.
  • Learn ways to conduct internal improvement audits that will reduce the risk of issues that would result in future complaints, recalls and the need for field alerts.