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Quality Risk Management - 2-day course
This course focuses on how to make the right quality decision in tough situations with finite information, short deadlines and high pressure! It shows you how to use ICHQ9 (Quality Risk Management) in times of crisis, in times of unpredictable variation and also in times when quality planning is required. Utilising a range of scenarios across the common pharma dosage forms, the course is jam-packed with real-life GMP non-conformance, product quality concerns, customer complaints, change control requests, ‘uncontrolled’ variations, potential market actions and field alerts – helping you to see how to make more effective risk-based decisions at your workplace.
Life is rarely black and white, and it is those situations in the grey zone where your powers of risk identification, risk assessment, prioritisation, execution and post-event verification are really tested. Taking a structured approach to decision making is critical in proposing the best ‘next steps’ and on this course you will spend time practicing a proven approach, evaluating your decisions and learning how to deal with a range of issues that challenge the quality attributes of pharma products. Hindsight tells us that the wrong decision (or no clear decision!) at the wrong time can make or break a company or its supply chain.
Some scenarios may only present themselves once or twice in a career, so attending this course concentrates a range of tough scenarios into two intensive days where we present some proven tools and then work alongside you to resolve several typical product quality issues.
Training Course Content
On completion of this course delegates will know and understand:
- How we humans make decisions. We are actually conditioned to think quickly, not accurately!
- How to design a simple, structured decision making process that will give you the right answers to the biggest challenges most of the time
- How to use ICH Q9 proactively in your decision making and in response to deviation, unexpected events and crises
- How to use risk-based decision making proactively to prevent problems, simplify systems, add value and minimise risk
- How to use the common risk-based decision making tools, practice their application and in doing so turn data into useful information
NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing, testing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our...