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.
Price: €250
About the course:
Outlines how to thoroughly investigate out of specification (OOS) and out of trend (OOT) results using scientifically justified evidence to determine the root cause:
Identifying and assessing OOS results
Phase I and Phase II laboratory investigations
Manufacturing investigations
Microbiological investigations
Out of trend (OOT) investigations
Tools to help identify root causes
Reviewing OOS/OOT results
How to conclude the investigation
- Easy Enrolment
- Self Paced
- Online Learning
- Certificate
Who is This Course For?
This course is designed for professionals in Good Manufacturing Practice (GMP) activities . It is particularly valuable for:
- Quality Assurance (QA) Personnel: Individuals involved in Good Manufacturing Practice (GMP) activities
- Qualified Person: involved in Good Manufacturing Practice (GMP) activities
- Quality Control (QC) Personnel: Individuals involved in Good Manufacturing Practice (GMP) activities
- Continuous Professional Development (CPD) Seekers: Individuals seeking to update their knowledge and skills to align with in Good Manufacturing Practice (GMP) activities
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.
Requirements
There are no prior qualifications or experience required to enrol in this course. It is open to all individuals interested in learning about GMP principles and practices.
