Trainings By Informa Markets
Informa


QUALITY RISK MANAGEMENT, CAPA & RCA WORKSHOP

Robust Root Cause Analysis for Effective CAPA

22 Nov - 24 Nov 2021


Workshop Overview

Robust root cause investigations are imperative for the business to reduce costs in the long run. It helps avoid repeat problems and wastages of time and resources. It is an important regulatory requirement worldwide which also helps an organisation with confidence during investigations and audit by the regulatory body. Every company manufacturing a product or a device has a responsibility to ensure that it is safe and meets its quality attributes including identity and strength. All pharma companies must be updated & compliant with the regulations. Failure to protect the patient results in costly, it causes loss of money and other resources due to recalls, regulatory actions, and loss of public confidence when inspection results are published. This unique 3-day online training is designed for Pharmaceutical Quality professionals. Delegates will examine Root Cause Analysis (RCA) techniques by applying them to practical examples from the industry. Learn how to meet Corrective Action Preventive Action (CAPA) audit expectations and maintain control over product and processes in a GMP environment.

Benefits of Attending


Apply Root Cause Analysis (RCA) to provide the answers to many of the problems through all aspects of quality assurance.
Understand risk, systems for causal analysis and techniques of data collection
Consider change analysis, barrier analysis and causal factor charts
Understand Critical Deviation Management (CDM)
Meet CAPA audit expectations o CAPA is the pharmaceutical process which outlines how to undertake activities to maintain control over product and processes in a GMP environment. o Without a thorough understanding of CAPA, and the accompanying need for RCA, companies will spend a lot of time and effort in repeatedly correcting faults rather than establishing procedures that will prevent these faults from occurring.
Training materials will be provided in digital form.

Who Should Attend?


  • QA Managers and Inspectors
  • QC Laboratory Managers
  • Qualified Persons
  • Regulatory Compliance Managers
  • Formulators
  • Process Validation and Scale-up Specialists
  • Process Development Managers
  • Chemical Engineer




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