Webinar ID:   ICT126

Quality Risk Management – A Practical Approach

  2 Hours

Categories:   Uncategorised,

The quality risk management is either an oversight topic or wrongly followed by many people. This webinar will help them to understand the key requirements about quality risk management and practically use of FMEA tool in pharmaceutical industry.

Why You Should Attend:

  • You will get a clear understanding about QRM requirements and the benefits in cGMP environment.
  • You will learn how to implement the Quality Risk Management into your Pharmaceutical Quality System.
  • How the QRM tool is used as proactive approach.
  • Make you aware about risks associated with old concept of RPN procedure.
  • What still many organisations not implemented QRM.

Areas Covered in the Session :

  • Introduction and overview of Webinar subject, Basics about Quality Risk Management in relation to cGMP
  • Brief understanding of FMEA tool for QRM , Why RPN calculation will not be much beneficial. Practical problems and solving the problems with the tools
  • Practical implementation of QRM in pharmaceutical domain
  • The journey of QRM implementation not yet reached up to many pharmaceutical areas. Discussion about those potential applications of QRM
  • Risk Ranking and Risk filtering process, Benefits of action priority table as compared to existing RPN calculation (SXOXD) approach.
  • Discussion and Q&A/Queries

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Contract Manufacturing Organizations
  • Data Integrity Teams
  • Documentation Departments
  • Supply Chain Departments
  • All those who are or planning to engage in the export of pharmaceutical product to regulated markets and achieve highest cGMP Compliance.


HitendraKumar Shah

Hitendrakumar Shah is a renown Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities.

His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is the CEO of NADH+ GxP Compliance Services and a popular figure on social media for his effective and easily understandable training bites.