The FDA's 21 CFR 211.192 states that any occurrence of unexpected events must be investigated, and that the investigation will extend to all batches related to that issue, which can have a huge time and cost impact.
Well-trained pharmaceutical quality professionals anticipate the unexpected and have tools and processes in place to manage these events as soon as they occur.
Learn how an enterprise Quality Management System (QMS), such as IQVIA SmartSolve® QMS, provides integrated, automated processes to manage, correct, and when possible, prevent the unexpected.
Download this Insight Brief for details.