Trainings By Informa Markets
Informa


Root Cause Analysis and Corrective and Preventive Actions Workshop (India)

Robust Root Cause Analysis for Effective CAPA

22 Mar - 24 Mar 2021   |   Virtual Course


Course 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 course is designed for personnel in the GMP regulated industries that are either new or need to enhance their understanding of performing root cause analysis as the result of deviations or incidents and the corresponding Corrective and Preventive Actions.

Program Focus

Understand how to perform robust RCA and appropriate CAPAs
Learn how to rationalize investigations and be more confident of root causes
Overcoming challenges for content and time constraints
Gain a greater understanding of regulatory requirements defined by FDA & EMA
Learn aspects & implications of FDA & EMA 483s & Warning Letters

Who Should Attend?


Industries

  • Pharmaceuticals
  • APIs
  • Life sciences
  • Bio-Pharmaceuticals

Designation

  • Vice Presidents
  • Deputy General Manager
  • Managers
  • Assistant Managers
  • General Manager
  • Associate Vice Presidents
  • CQA Head/ Plant Head
  • Senior Managers
  • Senior Executives

Departments

  • Quality Assurance
  • Product/Process Development
  • Quality Control
  • Engineering
  • R&D
  • Regulatory & Compliance
  • Manufacturing




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