Monday, 22 June 2015
1: Introduction to Laboratory Data Integrity; cGMP in the Pharma Lab
Day 1 introduces the fundamental concepts of laboratory data integrity in the context of working within a quality management system and as such this course also acts as an introduction/refresher to laboratory cGMP.
2: Applying Data Integrity in the Laboratory; Minimising Analytical Error
Day 2 deals with the effects of analytical errors on laboratory data integrity. This involves building an understanding of the nature and sources of analytical errors so that their effects can be minimised during testing, leading to high standards of data integrity and reduced numbers of OOS/OOE results due to laboratory errors.
3: How to Improve Data Integrity in the Pharma Lab
Day 3 focusses on improving laboratory data integrity and associated quality management systems by review of laboratory processes to identify data integrity risk, and implementation of appropriate solutions, paying particular attention to deficiencies that are commonly cited by regulatory authorities.
Visit the MTS website for more information and details of the open enrolment dates and locations.