ICH Q9 Guideline l Quality Risk Management l QRM in pharmaceutical industry l Question and answers

ICH Q9 l Quality Risk Management l QRM l risk management in pharmaceutical industry l Interview Question and answers
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Questions covered:
Q. What is ICH Q9 Guideline and why it is important ?
Q. What is May 2023 update for ICH Q9 ?
Q. What is definition of risk as per ICH Q9 ?
Q. What is definition of Quality Risk Management as per ICH Q9 ?
Q. What is systematic approach to risk assessment as per ICH Q9 ?
Q. What is definition of Severity as per ICH Q9 ?
Q. What is application scope of ICH Q9 ?
Q. What are the two main principles of QRM as per ICH Q9 ?
Q. What is overview of typical Quality risk management ?
Q. What are the steps for initiating QRM process ?
Q. What are the three fundamental questions that should be asked during risk assessment process as per ICH Q9 ?
Q. What is risk identification as per ICH Q9 ?
Q. What is risk Analysis as per ICH Q9 ?
Q. What is risk evaluation as per ICH Q9 ?
Q. Which Qualitative terms ICH Q9 recommends to express Risk ?
Q. What techniques are recommended for Risk Assessment in ICH Q9?
Q. How does ICH Q9 define Risk Communication?
Q. What is Risk Review according to ICH Q9 ?
Q. What is Risk based decision making as per ICH Q9 ?
Q. On which questions risk control process should focus ?
Q. As per ICH Q9 Which tools are considered as part of integrated Quality management documentation ?
Q. What are the other guidelines that are referred for Quality Risk Management in Pharmaceutical industry ?
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Keywords to find this video:
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[@PharmGrow]

Link to download ICH Q9 Guideline: database.ich.org/sites/default/files/Q9_Guideline.pdf

[@RAMKUMAR-fb7gt]

Useful

[@PharmGrow]

Thanks 👍