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The manufacture of sterile products is perhaps the most hazardous of all pharmaceutical production activities – failures can and sometimes do result in patient harm and death. That is why auditing of sterile filling operations is essential and why it is important that the auditor has the right knowledge and experience to conduct the audit with skill and professionalism. This short, focused course is designed to help auditors with little or no direct experience of auditing sterile filling operations to know where the risks lie, what questions to ask and how to assess whether or not processes are under control.