ICH Q9(R1) Quality Risk Management (QRM)
ICH Q9R1 Quality Risk Management has recently been updated by the regulators.
This update has been triggered by regulators seeing evidence of inadequacies in quality risk management processes, such as unjustified assumptions, unsystematic approaches, formality not commensurate to the risk, high levels of subjectivity, and that these can impact product availability.
This training course will bring participants right up-to-date with the latest Q9R1 requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.
This is an ideal opportunity to get up to speed with the recent changes and discuss the implications with an expert in this field.
Upcoming start dates
Suitability - Who should attend?
Benefits of Attending
- Keep up to date with the changes
- Understand the implications on products and processes
- Discuss new terms such as subjectivity, uncertainty, importance and complexity
- Stay abreast of the latest thinking on Quality Risk Management (QRM)
Request information - obligation free
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