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Quality Risk Management in Pharmaceuticals ICHQ9(R1)
Rating: 3.9 out of 5(30 ratings)
88 students

Quality Risk Management in Pharmaceuticals ICHQ9(R1)

Quality Risk Management in Pharmaceuticals ICHQ9(R1)
Created byHitendrakumar Shah
Last updated 11/2023
English
English [Auto],

What you'll learn

  • Performing quality risk management
  • Practical implementation of QRM
  • Updates in quality risk management
  • This course is self made for personal upgradation in pharmaceuticals

Course content

1 section • 5 lectures • 2h 31m total length

  • Introduction8:48

    Learn a simple, proactive approach to quality risk management in pharmaceuticals using failure mode effect analysis and risk priority number across the product life cycle.

  • Quality Risk Management ICHQ9(R1) Part-120:16

    Explore quality risk management under ich q9 r1, including fmea, risk assessment, rpn, action priority and heat map concepts, and its integration with q8 and q10 for patient protection.

  • Quality Risk Management ICHQ9(R1) Part-223:36

    Understand subjectivity in risk assessment and how to address product availability risk through prioritized mitigation, formality guided by uncertainty, importance, and complexity.

  • Quality Risk Management ICH Q9(R1) Part -325:27

    Explore how ICH Q9(R1) integrates with Q8 and Q10 to link product design, manufacturing, and quality management through practical risk assessment, FMEA, periodic reviews, and the action priority table.

  • Good Review Practices - A Risk Based Approach1:13:16

    Explore good review practices with a risk-based approach to documentation review. Learn regulatory expectations from FDA, MHRA, EU-GMP, and WHO, including validation and scientific review, counter checks, and reviewer qualification.

Requirements

  • The person should be full focussed during the session.

Description

The training lecture will help you to learn a brief introduction of the topic and scope Brief on ICH Quality Guidelines and Understanding guidelines for Quality Risk Management Updates in the new version of the 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 of Quality Risk Management (QRM) process and how to perform QRM by failure mode effect analysis tool. Action Priority Tablet concept/Heat map matrix Vote of Thanks - Q&A session.

Further, there is a small video lecture that will help you to understand Quality Risk Management principles, how it is simple and easy to implement and achieve the compliance level. We have explained this with simple examples.

The last lecture video will help you to learn further about Good Review practices. This training will include, some examples of Food and Drugs Administration (FDA) citations, regulatory expectations about the review, 10 key principles about good review practices, how to qualify reviewers, and many more.

Overall this training session will take you through an understanding of quality risk management, what is updated in the revised ICH Q9(R1) guideline, with practical examples and good review practices based on risk-based approach.


Who this course is for:

  • Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.

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