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Quality Risk Management ICH Q9(R1)
Brief introduction of the topic and scope
Brief on ICH Quality Guidelines
Understanding guideline for Quality Risk Management
Updates in new version of guideline ICH Q9 (R1)
Understanding of – Managing your risk has its own rewards.
Role of ICH Q9 with ICH Q8 and ICH Q10
Practical understanding on QRM process and how to perform QRM by FMEA tool.
Action Priority Tablet concept/Heat map matrix
Vote of Thanks - Q&A session
Overview of the webinar
The customer and regulatory agencies expectations are very clear. Quality Risk management is back bone in all - processes, procedures, facilities & systems, practices etc. The basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management are inter-related.
Because, during each quality management system requirement, the risk based approach is expected.
Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.
This training program will primarily focus on the concept and regulatory agencies expectations with practical approach for implementation of the Quality risk management as a part of pharmaceutical quality system.
Who should attend?
- Production
- QA
- QC
- Engineering
- R&D
- Data Integrity Team
- Compliance Team
Why should you attend?
The learning objectives are firstly understanding the regulatory agencies expectations with practical approach for Quality Risk Management.
How Pharmaceutical organisation personnel can ensure compliance and be able to comply the requirements.
The benefits are,
The person’s understanding about Quality Risk Management with special focus on practical implementation approach and also updation on current revised guideline (R1)
The person working in pharmaceutical will become compliant in QRM requirements.
Faculty - Mr.Hitendra Kumar Shah
A Quality-oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include Quality Compliance, Supplier Audit, building systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation, and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post-approval queries raised by regulatory agencies, etc.