Trainings2020-07-29T19:25:23-04:00

Leading Provider of Live and In-House Pharmaceutical & Life Sciences Trainings

QUALITY ASSURANCE MASTERS TRAINING (Virtual)

October 5–6, 2020 | Virtual Training
  • 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

QUALITY ASSURANCE MASTERS TRAINING

December 1–2, 2020 | Virtual Training
  • 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

San Francisco, 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

Edison, NJ
  • 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.