Lesson series
Out of specification and out of trend investigations are becoming increasingly important in the pharmaceutical industry due to an increase in the number of citations given for inadequate investigations.
In 2022 approximately 37 % of 483 warning letters from the FDA were issued due to failure to thoroughly review any unexplained discrepancy or the failure of the batch or any of its components to meet any of its specifications. In many cases this is down to companies being unaware of the regulatory guidance requirements while performing investigations.
This course is aimed at helping pharmaceutical companies to understand the guidance available to thoroughly investigate out of specifications and out of trends.
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Certificate
of Completion
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Self Paced
Course duration
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Keep Informed
Stay up to date with current legislation
The objective of this course is to equip those who complete the training with the knowledge and tools to adequately investigate and or review out of specifications and out of trends.
This course: This course outlines how to thoroughly investigate out of specification and out of trend results, using scientifically justified evidence to come to the root cause. It covers identifying and assessing OOS’s, phase I and phase II laboratory investigations, manufacturing investigations, microbiological investigations, out of trends, tools to help identify root causes, reviewing OOS/OOT’s and finally how to conclude the investigation.
Who is the course for:
Quality control personnel, Quality Assurance personnel involved in Good Manufacturing Practice (GMP) activities
Requirements:
There are no prerequisite requirements for completing this course
