Regulatory agencies are increasingly recommending companies take a risk-based approach to decision-making when it comes to manufacturing operations. So how can you adopt a risk-based thought process when it comes to quality and compliance?
To help you boat your risk-based thinking, we encourage you to check out the following free resources we offer:
Webinar | Deploying Risk-Based Thinking within Management Systems
Ernest Blanchard of SGS explains how to drive risk-based thinking across an organization’s quality management system (QMS).
What is Risk-Based Thinking?
Find out more about some risk assessment tools in this article covering Blanchar’s webinar on risk-based thinking.
ICH Q9: Quality Risk Management Revision Focuses on Six Topic Areas
The ICH Q9 revision adopts a risk-based approach grounded in science. Learn more about the six specific areas it focuses on.
Taking a Risk-Based Approach to QMS
Industry consultant Fenton Fong discusses how small pharma firms can use the ICH Quality Guidelines to take a risk-based approach to their QMS.
The EU MDR and Postmarket Surveillance
Two medical device experts explain why the EU Medical Device Regulation (EU MDR) means that medical device manufacturers must align with ISO 14971 when it comes to postmarket surveillance.
Did you know Redica Systems can provide your team with actionable insights you can use to drive a risk-based approach to compliance? For example, our platform allows users to easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject.
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