Application of Quality Risk Management (QRM) in the Manufacture of Pharmaceuticals

This webinar discusses the use of QRM, a FDA-approved tool for pharmaceutical manufacturers, in identifying and assessing risks at different stages of the manufacturing cycle, using both qualitative and quantitative tools.
  • Tuesday
  • July
  • 22
  • 2025
08:00 AM PDT | 11:00 AM EDT
Duration: 90 Minutes
IMG Dr. Ganesh Prasad
Webinar Id: 61182
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview

QRM is a power tool prescribed by FDA to pharmaceutical manufacturers to optimize manufacturing controls. Risk management is a dynamic process and needs to be applied at various stages of the manufacturing cycle. This lecture covers methodologies to identify risks in various stages of manufacturing operations, tools to assess the risk levels and build controls commensurate with risk. Qualitative and quantitative risk tools and their appropriate use will be discussed with suitable examples.   

Why you should Attend

To understand the principles and tools of quality risk management used in the manufacture of pharmaceutical products (non-sterile) in order to be able to identify and focus on critical stages as well as parameters and provide high level of assurance on the quality of finished product. Use of this approach reduces any subjectivity among employees and management in optimizing GMP controls based on risk.

Areas Covered in the Session

  • Risk Identification
  • Risk Evaluation 
  • Risk Control
  • Risk Review 
  • Various Risk Tools and Documentation

Who Will Benefit

  • Executives from QA/QC/Production/Technology transfer/warehouse/Engineering

Speaker Profile

Dr. Ganesh Prasad is a freelance Pharma consultant in India under the banner ‘Q_Pharma consulting India & holds a doctorate degree in Organic Chemistry from Indian Institute of Science, Bengaluru. Previously, he worked at senior levels in pharmaceutical companies like Apotex Pharmachem India Pvt Ltd, ICI Pharmaceuticals, India and other organisations heading QA/QC/Process functions. He has also worked as scientist in the US FDA laboratory in Washington and other reputed institutions in USA/ Canada/India. He has together more than 30 years of experience together in quality assurance function, research in academia and industry. As a consultant he has assisted many pharmaceutical companies towards establishing cGMP standards of US FDA, European and Indian regulatory agencies. He also conducts third party quality audits of pharmaceutical manufacturers. He has conducted many public and in-house workshops and delivered invited lectures in forums like UBM, ISPE, DIA and so on.