Auditing Deviations, Product Complaints, and CAPA Systems

Among the essential elements of a well-established Quality Management System (QMS), deviation handling plays a key role in assuring quality in products and by contributing to continuous improvement. Manufacturers are expected to “establish processes and define appropriate controls for measurement and analysis to identify nonconformities and potential nonconformities, defining when and how corrections, corrective actions, or preventive actions should be undertaken. These actions should be commensurate with the significance or risk of the nonconformity or potential nonconformity. GMPs have evolved as a consequence and of the inherent risks to the product during manufacturing operations in order to prevent significant deviations. More recently, Quality Risk Management (QRM) has been proposed as a strategy to manage risk in a systematic and documented manner, and has become a requirement of modern GMPs as recommended by international standards like WHO or ICH.

 

  • Understand the main objectives for conducting laboratory audit and inspections
  • Discuss how to prepare for conducting an audit
  • Learn how to assembling an audit team
  • Identify the areas of deficiencies
  • Review the do’s and don’ts during the audit
  • The New EU Medical Device Regulation
  • Prepare the audit report
  • Implementation of a company wide data integrity program

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