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Risk management is key to effective life sciences manufacturing. While it is important in any business, in the life sciences, where patients’ lives are on the line, risk management is critical. Life sciences manufacturing is particularly in the spotlight now as companies race to manufacture the COVID-19 vaccine as quickly as possible. Even without the pandemic, regulations and standards were trending to an increased focus on risk management and risk-based thinking throughout a business.
Risk is a complex topic because the very word doesn’t mean the same thing across the board. The word itself has a negative connotation, but in the most recent standards from the International Organization for Standardization (ISO) it can refer to anything unknown — even something good. Then there’s the question of what risk management entails, who’s responsible for mitigation and how to carry out that mitigation. In life sciences manufacturing, these questions are pivotal for compliance, quality and safety.
Read the full article here: Risk Management Key to Life Sciences Manufacturing