Project & Quality Training International

Risk Management

Risk Management has become an important concept within the Life Science Industry.

The acceptance by the various governments of the ICH Q9 and ICH Q10 resulted in the pharmaceutical industry to the actual implementation of risk management throughout the organization. For the other sectors within the life sciences industry there are different guidelines and / or methodologies that can and should be applied (e.g. medical devices ISO14971, HACCP food, general ISO31000 and 31010). The practical implementation of risk management methods is very important.

Risk Management is an overall process with respect to risk identification, risk analysis and risk assessment with the main pillar consumer and / or patient safety. The objective is to reduce or better
eliminate the risks.

Risk Management is applied in many areas within the organization. Risk Management is used for example at implementing changes, technology transfer, assessing deviations, allowing new or reviewing existing suppliers, determining the depth of the qualification and/ or validation activities. All these risk assessments using their own techniques. In this training we will explain some of these techniques and practical usage throughout workshops.

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